Trial Outcomes & Findings for To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) (NCT NCT00754065)
NCT ID: NCT00754065
Last Updated: 2024-11-20
Results Overview
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
COMPLETED
PHASE3
409 participants
Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
2024-11-20
Participant Flow
The date of first subject first visit was 08 Sep 2008. The date of last subject last visit was 10 May 2011.
A total of 776 participants were screened; 367 failed Screening, and 409 were randomized 1:1, of which 14 never received treatment, and 395 were treated (EV/DNG=191; EE/NGM=204). A total of 203 subjects (99 received EV/DNG and 104 EE/NGM) in the US and 192 (92 received EV/DNG and 100 EE/NGM) in Canada received at least one dose of the study drug.
Participant milestones
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
206
|
|
Overall Study
Participants Received Treatment
|
191
|
204
|
|
Overall Study
Cycle 6
|
141
|
153
|
|
Overall Study
COMPLETED
|
122
|
126
|
|
Overall Study
NOT COMPLETED
|
81
|
80
|
Reasons for withdrawal
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Overall Study
Never received treatment
|
12
|
2
|
|
Overall Study
Adverse Event
|
19
|
25
|
|
Overall Study
Lost to Follow-up
|
7
|
11
|
|
Overall Study
Protocol Violation
|
12
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Pregnancy
|
6
|
0
|
|
Overall Study
Reason not specified or unknown, etc.
|
21
|
27
|
Baseline Characteristics
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Baseline characteristics by cohort
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=191 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=204 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.0 Years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
26.5 Years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
26.3 Years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
395 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
168 Participants
n=99 Participants
|
180 Participants
n=107 Participants
|
348 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)Population: All participants in Full Analysis Set (FAS) with assessment for this outcome measure
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=158 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=173 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6
|
43.05 mm
Standard Deviation 23.58
|
34.97 mm
Standard Deviation 25.90
|
SECONDARY outcome
Timeframe: From Baseline to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=148 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=157 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
Days 1-21
|
-1.6 Tablets
Standard Deviation 9.9
|
-3.0 Tablets
Standard Deviation 10.3
|
|
The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
Days 22-28
|
-5.8 Tablets
Standard Deviation 7.5
|
-4.6 Tablets
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: From Baseline to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=125 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=126 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
Days 22-28
|
-5.3 Tablets
Standard Deviation 7.6
|
-5.2 Tablets
Standard Deviation 8.9
|
|
The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
Days 1-21
|
-2.3 Tablets
Standard Deviation 8.3
|
-3.5 Tablets
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=140 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=153 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Pelvic pain
|
-1.921 Days
Standard Deviation 2.219
|
-1.830 Days
Standard Deviation 2.093
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Breast tenderness
|
-0.536 Days
Standard Deviation 1.702
|
-0.497 Days
Standard Deviation 1.755
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Nausea or vomiting
|
-0.207 Days
Standard Deviation 1.089
|
-0.229 Days
Standard Deviation 0.892
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Headache
|
-1.950 Days
Standard Deviation 2.264
|
-1.425 Days
Standard Deviation 2.223
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Bloating or swelling
|
-1.179 Days
Standard Deviation 2.051
|
-1.131 Days
Standard Deviation 1.996
|
SECONDARY outcome
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=121 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=124 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Bloating or swelling
|
-0.959 Days
Standard Deviation 1.855
|
-1.379 Days
Standard Deviation 1.868
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Headache
|
-1.909 Days
Standard Deviation 2.317
|
-1.419 Days
Standard Deviation 2.053
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Pelvic pain
|
-2.091 Days
Standard Deviation 2.074
|
-2.065 Days
Standard Deviation 2.233
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Breast tenderness
|
-0.545 Days
Standard Deviation 1.727
|
-0.677 Days
Standard Deviation 1.699
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Nausea or vomiting
|
-0.248 Days
Standard Deviation 1.113
|
-0.266 Days
Standard Deviation 1.148
|
SECONDARY outcome
Timeframe: Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=143 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=157 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Bloating or swelling
|
-0.531 Days
Standard Deviation 2.325
|
-0.210 Days
Standard Deviation 2.056
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Headache
|
-1.077 Days
Standard Deviation 3.407
|
-0.968 Days
Standard Deviation 2.688
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Pelvic pain
|
-0.399 Days
Standard Deviation 2.198
|
-0.624 Days
Standard Deviation 2.147
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Breast tenderness
|
-0.580 Days
Standard Deviation 1.798
|
-0.248 Days
Standard Deviation 1.970
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Nausea or vomiting
|
-0.182 Days
Standard Deviation 1.555
|
-0.172 Days
Standard Deviation 1.507
|
SECONDARY outcome
Timeframe: Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=129 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Nausea or vomiting
|
-0.298 Days
Standard Deviation 1.391
|
-0.240 Days
Standard Deviation 1.457
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Headache
|
-1.121 Days
Standard Deviation 3.122
|
-0.767 Days
Standard Deviation 2.983
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Pelvic pain
|
-0.274 Days
Standard Deviation 2.444
|
-0.643 Days
Standard Deviation 2.113
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Bloating or swelling
|
-0.492 Days
Standard Deviation 1.944
|
-0.279 Days
Standard Deviation 2.140
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Breast tenderness
|
-0.274 Days
Standard Deviation 1.467
|
-0.217 Days
Standard Deviation 2.042
|
SECONDARY outcome
Timeframe: From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=139 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=153 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Bloating or swelling
|
-0.137 Days
Standard Deviation 0.773
|
-1.131 Days
Standard Deviation 1.996
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Breast tenderness
|
-0.043 Days
Standard Deviation 0.588
|
-0.497 Days
Standard Deviation 1.755
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Headache
|
-0.424 Days
Standard Deviation 0.901
|
-1.425 Days
Standard Deviation 2.223
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Pelvic pain
|
-0.273 Days
Standard Deviation 1.013
|
-1.830 Days
Standard Deviation 2.093
|
|
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Nausea or vomiting
|
-0.043 Days
Standard Deviation 0.378
|
-0.229 Days
Standard Deviation 0.892
|
SECONDARY outcome
Timeframe: From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=121 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=124 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Headache
|
-0.537 Days
Standard Deviation 0.904
|
-1.419 Days
Standard Deviation 2.053
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Nausea or vomiting
|
-0.033 Days
Standard Deviation 0.407
|
-0.266 Days
Standard Deviation 1.148
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Pelvic pain
|
-0.322 Days
Standard Deviation 0.977
|
-2.065 Days
Standard Deviation 2.233
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Bloating or swelling
|
-0.107 Days
Standard Deviation 0.716
|
-1.379 Days
Standard Deviation 1.868
|
|
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Breast tenderness
|
-0.033 Days
Standard Deviation 0.515
|
-0.677 Days
Standard Deviation 1.699
|
SECONDARY outcome
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=154 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=171 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
|
36.92 mm
Standard Deviation 24.48
|
32.28 mm
Standard Deviation 25.77
|
SECONDARY outcome
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=122 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=126 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
|
45.89 mm
Standard Deviation 23.12
|
39.19 mm
Standard Deviation 27.68
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=164 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Bleeding or Spotting in Reference Period 1
|
19.0 Days
Standard Deviation 10.9
|
23.7 Days
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=143 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=156 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Bleeding or Spotting in Reference Period 2
|
1.3 Days
Standard Deviation 9.2
|
18.8 Days
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Bleeding or Spotting in Reference Period 3
|
14.1 Days
Standard Deviation 10.4
|
19.1 Days
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=125 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Bleeding or Spotting in Reference Period 4
|
12.8 Days
Standard Deviation 9.1
|
19.4 Days
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=164 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Bleeding / Spotting Episodes in Reference Period 1
|
3.6 Episodes
Standard Deviation 1.4
|
3.7 Episodes
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=143 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=156 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Bleeding / Spotting Episodes in Reference Period 2
|
3.3 Episodes
Standard Deviation 1.4
|
3.4 Episodes
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Bleeding / Spotting Episodes in Reference Period 3
|
3.0 Episodes
Standard Deviation 1.4
|
3.3 Episodes
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=125 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Bleeding / Spotting Episodes in Reference Period 4
|
3.0 Episodes
Standard Deviation 1.6
|
3.7 Episodes
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=160 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Bleeding / Spotting Episodes in Reference Period 1
|
4.82 Days
Standard Deviation 2.50
|
6.20 Days
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=136 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Bleeding / Spotting Episodes in Reference Period 2
|
4.46 Days
Standard Deviation 2.31
|
5.71 Days
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=122 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Bleeding / Spotting Episodes in Reference Period 3
|
4.70 Days
Standard Deviation 2.68
|
5.85 Days
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=113 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Bleeding / Spotting Episodes in Reference Period 4
|
4.25 Days
Standard Deviation 1.57
|
5.65 Days
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=160 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
|
7.8 Days
Standard Deviation 5.5
|
9.0 Days
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=136 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
|
6.2 Days
Standard Deviation 3.5
|
7.5 Days
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=122 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Bleeding / Spotting Episodes in Reference Period 3
|
6.2 Days
Standard Deviation 3.5
|
7.4 Days
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=113 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Bleeding / Spotting Episodes in Reference Period 4
|
5.7 Days
Standard Deviation 3.0
|
7.1 Days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=160 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
|
5.1 Days
Standard Deviation 5.3
|
5.1 Days
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=136 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
|
3.3 Days
Standard Deviation 3.2
|
3.5 Days
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=122 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3
|
3.0 Days
Standard Deviation 3.0
|
3.1 Days
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=113 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4
|
2.7 Days
Standard Deviation 3.3
|
2.8 Days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=164 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Spotting-only in Reference Period 1
|
9.3 Days
Standard Deviation 7.5
|
8.6 Days
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=143 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=156 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Spotting-only in Reference Period 2
|
6.8 Days
Standard Deviation 6.2
|
6.4 Days
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Spotting-only in Reference Period 3
|
6.6 Days
Standard Deviation 7.1
|
6.3 Days
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=125 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Days With Spotting-only in Reference Period 4
|
5.6 Days
Standard Deviation 6.1
|
5.6 Days
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=164 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=180 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Spotting-only Episodes in Reference Period 1
|
1.2 Episodes
Standard Deviation 1.3
|
0.5 Episodes
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=143 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=156 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Spotting-only Episodes in Reference Period 2
|
1.0 Episodes
Standard Deviation 1.2
|
0.5 Episodes
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=138 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Spotting-only Episodes in Reference Period 3
|
0.7 Episodes
Standard Deviation 1.1
|
0.3 Episodes
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=125 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=116 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Spotting-only Episodes in Reference Period 4
|
0.6 Episodes
Standard Deviation 1.1
|
0.2 Episodes
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=97 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=59 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Spotting-only Episodes in Reference Period 1
|
2.64 Days
Standard Deviation 1.67
|
2.53 Days
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=73 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=48 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Spotting-only Episodes in Reference Period 2
|
2.74 Days
Standard Deviation 1.57
|
2.77 Days
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=51 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=26 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Spotting-only Episodes in Reference Period 3
|
2.75 Days
Standard Deviation 1.49
|
2.44 Days
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=49 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=21 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Length of Spotting-only Episodes in Reference Period 4
|
2.77 Days
Standard Deviation 1.77
|
2.10 Days
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=97 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=59 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Spotting-only Episodes in Reference Period 1
|
3.3 Days
Standard Deviation 2.4
|
2.8 Days
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=73 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=48 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Spotting-only Episodes in Reference Period 2
|
3.2 Days
Standard Deviation 1.9
|
3.1 Days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=51 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=26 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Spotting-only Episodes in Reference Period 3
|
3.5 Days
Standard Deviation 2.2
|
2.8 Days
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=49 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=21 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Spotting-only Episodes in Reference Period 4
|
3.2 Days
Standard Deviation 2.3
|
2.2 Days
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: From Day 1 to Day 90Population: All participants in FAS with assessment for this outcome measure
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=97 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=59 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
|
1.2 Days
Standard Deviation 2.1
|
0.5 Days
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: From Day 91 to Day 180Population: All participants in FAS with assessment for this outcome measure
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=73 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=48 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
|
1.0 Days
Standard Deviation 1.5
|
0.7 Days
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: From Day 181 to Day 270Population: All participants in FAS with assessment for this outcome measure
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=51 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=26 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3
|
1.4 Days
Standard Deviation 2.1
|
0.6 Days
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: From Day 271 to Day 360Population: All participants in FAS with assessment for this outcome measure
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=49 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=21 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4
|
0.9 Days
Standard Deviation 1.9
|
0.2 Days
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=180 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=188 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
without withdrawal bleeding
|
25.0 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
with withdrawal bleeding
|
75.0 Percentage of participants
|
87.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=167 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=182 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
without withdrawal bleeding
|
21.0 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
with withdrawal bleeding
|
79.0 Percentage of participants
|
92.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=157 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
without withdrawal bleeding
|
17.7 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
with withdrawal bleeding
|
82.3 Percentage of participants
|
91.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=110 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=110 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
without withdrawal bleeding
|
58.2 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
with withdrawal bleeding
|
41.8 Percentage of participants
|
80.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=135 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=164 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Length of Withdrawal Bleeding Episodes at Cycle 1
|
4.2 Days
Standard Deviation 2.3
|
6.0 Days
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=168 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Length of Withdrawal Bleeding Episodes at Cycle 3
|
4.3 Days
Standard Deviation 2.1
|
5.8 Days
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=121 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=144 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Length of Withdrawal Bleeding Episodes at Cycle 6
|
4.6 Days
Standard Deviation 3.2
|
5.7 Days
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=46 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=89 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Length of Withdrawal Bleeding Episodes at Cycle 13
|
4.8 Days
Standard Deviation 1.8
|
5.5 Days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=135 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=164 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
|
3.2 Scores on a scale
Standard Deviation 0.9
|
4.0 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=168 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
|
3.2 Scores on a scale
Standard Deviation 0.9
|
4.2 Scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=121 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=144 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
|
3.4 Scores on a scale
Standard Deviation 0.8
|
4.0 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=46 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=89 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13
|
3.5 Scores on a scale
Standard Deviation 0.7
|
4.1 Scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=135 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=164 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Onset of Withdrawal Bleeding Episodes at Cycle 1
|
4.7 Days
Standard Deviation 7.0
|
4.0 Days
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=132 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=168 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Onset of Withdrawal Bleeding Episodes at Cycle 3
|
4.3 Days
Standard Deviation 7.0
|
3.3 Days
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=121 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=144 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Onset of Withdrawal Bleeding Episodes at Cycle 6
|
5.3 Days
Standard Deviation 7.7
|
3.1 Days
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=46 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=89 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Onset of Withdrawal Bleeding Episodes at Cycle 13
|
1.1 Days
Standard Deviation 2.2
|
2.1 Days
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=180 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=188 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
without absence of intracyclic bleeding
|
21.7 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
with absence of intracyclic bleeding
|
78.3 Percentage of participants
|
91.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=167 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=182 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
with absence of intracyclic bleeding
|
79.6 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
without absence of intracyclic bleeding
|
20.4 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=157 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
with absence of intracyclic bleeding
|
81.6 Percentage of participants
|
80.3 Percentage of participants
|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
without absence of intracyclic bleeding
|
18.4 Percentage of participants
|
19.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=110 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=110 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
with absence of intracyclic bleeding
|
82.7 Percentage of participants
|
93.6 Percentage of participants
|
|
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
without absence of intracyclic bleeding
|
17.3 Percentage of participants
|
6.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=180 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=188 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Episodes at Cycle 1
|
0.3 Episodes
Standard Deviation 0.5
|
0.1 Episodes
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=167 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=182 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Episodes at Cycle 3
|
0.2 Episodes
Standard Deviation 0.5
|
0.2 Episodes
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=157 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Episodes at Cycle 6
|
0.2 Episodes
Standard Deviation 0.4
|
0.2 Episodes
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=110 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=110 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Episodes at Cycle 13
|
0.2 Episodes
Standard Deviation 0.4
|
0.1 Episodes
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=39 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=16 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
|
6.7 Days
Standard Deviation 8.5
|
6.2 Days
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=34 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=26 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
|
6.6 Days
Standard Deviation 6.0
|
4.2 Days
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=27 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=31 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
|
5.0 Days
Standard Deviation 4.9
|
5.2 Days
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=19 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=7 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Maximum Length of Intracyclic Bleeding Episodes at Cycle 13
|
3.0 Days
Standard Deviation 2.2
|
6.0 Days
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=180 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=188 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Days at Cycle 1
|
1.5 Days
Standard Deviation 4.8
|
0.5 Days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=167 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=182 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Days at Cycle 3
|
1.4 Days
Standard Deviation 3.8
|
0.7 Days
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=157 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Days at Cycle 6
|
0.9 Days
Standard Deviation 2.9
|
1.1 Days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=110 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=110 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Number of Intracyclic Bleeding Days at Cycle 13
|
0.5 Days
Standard Deviation 1.5
|
0.4 Days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: At Cycle 1 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=39 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=16 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Spotting
|
46.2 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Light
|
23.1 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Normal
|
15.4 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Heavy
|
15.4 Percentage of participants
|
12.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 3 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=34 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=26 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Spotting
|
47.1 Percentage of participants
|
57.7 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Heavy
|
8.8 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Light
|
23.5 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Normal
|
20.6 Percentage of participants
|
23.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=27 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=31 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Spotting
|
44.4 Percentage of participants
|
61.3 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Light
|
25.9 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Normal
|
18.5 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Heavy
|
11.1 Percentage of participants
|
16.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=19 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=7 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Spotting
|
31.6 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Light
|
52.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Normal
|
10.5 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Heavy
|
5.3 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycles 2 to 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=184 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=195 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
Yes
|
53.8 Percentage of participants
|
40.5 Percentage of participants
|
|
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
No
|
46.2 Percentage of participants
|
59.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycles 2 to 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=184 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=195 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
Yes
|
62.0 Percentage of participants
|
49.7 Percentage of participants
|
|
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
No
|
38.0 Percentage of participants
|
50.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Positive well-being
|
49.66 Scores on a scale
Standard Deviation 5.99
|
50.29 Scores on a scale
Standard Deviation 6.60
|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Self-control
|
0.69 Scores on a scale
Standard Deviation 9.04
|
0.12 Scores on a scale
Standard Deviation 9.17
|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
General health
|
81.81 Scores on a scale
Standard Deviation 13.94
|
81.12 Scores on a scale
Standard Deviation 13.38
|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Global score
|
0.41 Scores on a scale
Standard Deviation 6.16
|
1.10 Scores on a scale
Standard Deviation 6.96
|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Anxiety
|
0.3 Scores on a scale
Standard Deviation 13.9
|
2.8 Scores on a scale
Standard Deviation 16.8
|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Depressed mood
|
0.18 Scores on a scale
Standard Deviation 11.10
|
-1.04 Scores on a scale
Standard Deviation 13.73
|
|
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Vitality
|
-0.17 Scores on a scale
Standard Deviation 8.98
|
0.19 Scores on a scale
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Anxiety
|
-1.2 Scores on a scale
Standard Deviation 16.6
|
-0.8 Scores on a scale
Standard Deviation 20.4
|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Depressed mood
|
-0.65 Scores on a scale
Standard Deviation 13.18
|
-0.98 Scores on a scale
Standard Deviation 15.96
|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Positive well-being
|
0.60 Scores on a scale
Standard Deviation 8.13
|
0.38 Scores on a scale
Standard Deviation 8.43
|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Global score
|
-0.14 Scores on a scale
Standard Deviation 7.41
|
-0.18 Scores on a scale
Standard Deviation 9.08
|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Self-control
|
-0.49 Scores on a scale
Standard Deviation 9.47
|
-0.16 Scores on a scale
Standard Deviation 9.19
|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
General health
|
0.86 Scores on a scale
Standard Deviation 14.46
|
1.35 Scores on a scale
Standard Deviation 16.15
|
|
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Vitality
|
0.28 Scores on a scale
Standard Deviation 10.99
|
-0.51 Scores on a scale
Standard Deviation 11.22
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
|
1.13 Scores on a scale
Standard Deviation 14.09
|
3.44 Scores on a scale
Standard Deviation 14.32
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
|
1.93 Scores on a scale
Standard Deviation 14.37
|
2.13 Scores on a scale
Standard Deviation 15.21
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
|
0.12 Scores on a scale
Standard Deviation 9.76
|
2.19 Scores on a scale
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
|
-0.44 Scores on a scale
Standard Deviation 12.36
|
0.39 Scores on a scale
Standard Deviation 14.35
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 \[very poor, poor, fair, good, very good\]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=118 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=135 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
|
0.54 Scores on a scale
Standard Deviation 9.03
|
0.08 Scores on a scale
Standard Deviation 10.87
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 \[very poor, poor, fair, good, very good\]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=105 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=107 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
|
-1.38 Scores on a scale
Standard Deviation 12.11
|
-1.71 Scores on a scale
Standard Deviation 17.07
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 \[very poor, poor, fair, good, very good\]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=140 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=153 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
|
1.50 Scores on a scale
Standard Deviation 12.16
|
3.08 Scores on a scale
Standard Deviation 14.83
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 \[very poor, poor, fair, good, very good\]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=117 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=125 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
|
-0.66 Scores on a scale
Standard Deviation 14.31
|
2.83 Scores on a scale
Standard Deviation 18.23
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=28 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=35 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
|
-0.18 Scores on a scale
Standard Deviation 12.84
|
5.13 Scores on a scale
Standard Deviation 17.43
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=19 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=30 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
|
-1.97 Scores on a scale
Standard Deviation 18.09
|
4.39 Scores on a scale
Standard Deviation 16.40
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
|
1.22 Scores on a scale
Standard Deviation 12.0
|
2.77 Scores on a scale
Standard Deviation 14.36
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
|
2.72 Scores on a scale
Standard Deviation 14.45
|
2.37 Scores on a scale
Standard Deviation 15.19
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
|
-0.30 Scores on a scale
Standard Deviation 11.15
|
0.41 Scores on a scale
Standard Deviation 13.52
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
|
1.01 Scores on a scale
Standard Deviation 12.58
|
1.75 Scores on a scale
Standard Deviation 13.94
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
|
0.56 Scores on a scale
Standard Deviation 9.83
|
1.27 Scores on a scale
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
|
0.73 Scores on a scale
Standard Deviation 10.28
|
1.34 Scores on a scale
Standard Deviation 13.03
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=110 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=129 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
|
-0.1 Scores on a scale
Standard Deviation 0.7
|
0.1 Scores on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=93 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=107 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
|
0.0 Scores on a scale
Standard Deviation 0.6
|
0.1 Scores on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
|
-0.1 Scores on a scale
Standard Deviation 0.7
|
0.0 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
|
-0.1 Scores on a scale
Standard Deviation 0.8
|
0.0 Scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
Very much improved
|
21.1 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
Much improved
|
41.5 Percentage of participants
|
25.2 Percentage of participants
|
|
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
Minimally improved
|
27.2 Percentage of participants
|
33.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
Very much improved
|
37.9 Percentage of participants
|
20.3 Percentage of participants
|
|
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
Much improved
|
32.3 Percentage of participants
|
26.6 Percentage of participants
|
|
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
Minimally improved
|
15.3 Percentage of participants
|
27.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=147 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=155 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
Very much improved
|
25.2 Percentage of participants
|
11.6 Percentage of participants
|
|
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
Much improved
|
32.7 Percentage of participants
|
30.3 Percentage of participants
|
|
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
Minimally improved
|
29.3 Percentage of participants
|
32.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At Cycle 13 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=124 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=128 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
Minimally improved
|
16.9 Percentage of participants
|
28.1 Percentage of participants
|
|
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
Very much improved
|
33.9 Percentage of participants
|
17.2 Percentage of participants
|
|
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
Much improved
|
35.5 Percentage of participants
|
25.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=191 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=204 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
15 mm VAS decrease
|
68.1 Percentage of participants
|
54.4 Percentage of participants
|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
30 mm VAS decrease
|
58.1 Percentage of participants
|
42.6 Percentage of participants
|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
45 mm VAS decrease
|
38.2 Percentage of participants
|
26.0 Percentage of participants
|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
25% VAS decrease
|
67.0 Percentage of participants
|
54.4 Percentage of participants
|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
50% VAS decrease
|
56.0 Percentage of participants
|
42.2 Percentage of participants
|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
75% VAS decrease
|
38.2 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
Half-SD decrease
|
70.2 Percentage of participants
|
59.8 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)Population: All participants in FAS with assessment for this outcome measure
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Outcome measures
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=141 Participants
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=153 Participants
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6
|
43.60 mm
Standard Deviation 29.16
|
34.55 mm
Standard Deviation 30.64
|
Adverse Events
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Ortho Tri-Cyclen Lo
Serious adverse events
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=191 participants at risk
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=204 participants at risk
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/191
|
0.49%
1/204
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/191
|
0.49%
1/204
|
|
Infections and infestations
Pharyngitis bacterial
|
0.52%
1/191
|
0.00%
0/204
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/191
|
0.49%
1/204
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/191
|
0.98%
2/204
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/191
|
0.49%
1/204
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.52%
1/191
|
0.00%
0/204
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/191
|
0.49%
1/204
|
Other adverse events
| Measure |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
n=191 participants at risk
Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
|
Ortho Tri-Cyclen Lo
n=204 participants at risk
Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
14.7%
28/191
|
17.2%
35/204
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
6/191
|
2.0%
4/204
|
|
Gastrointestinal disorders
Constipation
|
1.6%
3/191
|
2.5%
5/204
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
5/191
|
0.98%
2/204
|
|
Gastrointestinal disorders
Nausea
|
14.1%
27/191
|
14.7%
30/204
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
19/191
|
4.4%
9/204
|
|
General disorders
Swelling
|
1.6%
3/191
|
2.5%
5/204
|
|
Immune system disorders
Seasonal allergy
|
1.0%
2/191
|
2.9%
6/204
|
|
Infections and infestations
Fungal infection
|
3.1%
6/191
|
2.5%
5/204
|
|
Infections and infestations
Influenza
|
4.2%
8/191
|
2.0%
4/204
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
22/191
|
9.8%
20/204
|
|
Infections and infestations
Sinusitis
|
6.8%
13/191
|
4.9%
10/204
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
12/191
|
5.4%
11/204
|
|
Infections and infestations
Urinary tract infection
|
12.0%
23/191
|
4.9%
10/204
|
|
Infections and infestations
Vaginitis bacterial
|
3.7%
7/191
|
3.9%
8/204
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.1%
4/191
|
0.98%
2/204
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
5/191
|
0.98%
2/204
|
|
Investigations
Weight increased
|
2.1%
4/191
|
2.0%
4/204
|
|
Investigations
White blood cells urine positive
|
2.6%
5/191
|
2.5%
5/204
|
|
Investigations
Human papilloma virus test positive
|
5.2%
10/191
|
3.4%
7/204
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
5/191
|
0.98%
2/204
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
8/191
|
3.9%
8/204
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.52%
1/191
|
2.5%
5/204
|
|
Nervous system disorders
Dizziness
|
1.6%
3/191
|
2.5%
5/204
|
|
Nervous system disorders
Headache
|
29.3%
56/191
|
24.5%
50/204
|
|
Nervous system disorders
Migraine
|
2.1%
4/191
|
1.5%
3/204
|
|
Nervous system disorders
Sinus headache
|
2.1%
4/191
|
0.00%
0/204
|
|
Psychiatric disorders
Anxiety
|
0.52%
1/191
|
2.5%
5/204
|
|
Psychiatric disorders
Mood swings
|
1.6%
3/191
|
3.4%
7/204
|
|
Reproductive system and breast disorders
Amenorrhoea
|
10.5%
20/191
|
0.49%
1/204
|
|
Reproductive system and breast disorders
Breast pain
|
2.1%
4/191
|
1.5%
3/204
|
|
Reproductive system and breast disorders
Breast tenderness
|
12.0%
23/191
|
13.2%
27/204
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
11.5%
22/191
|
9.8%
20/204
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.4%
18/191
|
8.3%
17/204
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.1%
4/191
|
2.5%
5/204
|
|
Reproductive system and breast disorders
Menstruation delayed
|
2.6%
5/191
|
1.5%
3/204
|
|
Reproductive system and breast disorders
Metrorrhagia
|
16.2%
31/191
|
12.3%
25/204
|
|
Reproductive system and breast disorders
Pelvic pain
|
24.1%
46/191
|
23.0%
47/204
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
2/191
|
2.9%
6/204
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.6%
5/191
|
2.5%
5/204
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.1%
4/191
|
0.00%
0/204
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and/or Principal Investigator shall furnish the Sponsor with a copy of any proposed publication material at least sixty (60) days in advance of the date of submission for publication or presentation so that the proposed publication may be edited appropriately to remove any confidential information before publication or the Sponsor shall have sufficient additional time (not to exceed sixty (60) days) to file a patent application for such Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER