Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy (NCT NCT00996580)
NCT ID: NCT00996580
Last Updated: 2013-06-24
Results Overview
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
COMPLETED
PHASE3
3597 participants
Day 1 up to year 1
2013-06-24
Participant Flow
A total of 4,962 subjects were screened for participation in this study, and 3,597 took at least one dose of investigational product (Safety population).
Participant milestones
| Measure |
DR-103
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
|---|---|
|
Overall Study
STARTED
|
3597
|
|
Overall Study
Pregnancy Intent-to-Treat Population
|
3019
|
|
Overall Study
COMPLETED
|
2144
|
|
Overall Study
NOT COMPLETED
|
1453
|
Reasons for withdrawal
| Measure |
DR-103
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
|---|---|
|
Overall Study
Adverse Event
|
466
|
|
Overall Study
Lost to Follow-up
|
480
|
|
Overall Study
Noncompliance with the protocol
|
137
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Pregnancy
|
68
|
|
Overall Study
Protocol Violation
|
16
|
|
Overall Study
Sponsor requested participant withdrawal
|
35
|
|
Overall Study
Withdrawal by Subject
|
217
|
|
Overall Study
Other
|
29
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
Baseline characteristics by cohort
| Measure |
DR-103
n=3597 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
|---|---|
|
Age Continuous
|
27.4 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3597 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
14 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
78 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
10 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
696 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
2324 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
404 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
71 participants
n=99 Participants
|
|
Height
|
64.6 inches
STANDARD_DEVIATION 2.7 • n=99 Participants
|
|
Weight
|
162.5 pounds
STANDARD_DEVIATION 43.2 • n=99 Participants
|
|
Body Mass Index
|
27.4 kg/m^2
STANDARD_DEVIATION 7.0 • n=99 Participants
|
|
Systolic Blood Pressure
|
113.1 mmHg
STANDARD_DEVIATION 10.4 • n=99 Participants
|
|
Diastolic Blood Pressure
|
72.3 mmHg
STANDARD_DEVIATION 8.3 • n=99 Participants
|
|
Heart Rate
|
74.6 beats/minute
STANDARD_DEVIATION 10.0 • n=99 Participants
|
|
Oral Contraceptive Use History
Continuous user
|
1570 participants
n=99 Participants
|
|
Oral Contraceptive Use History
New Start
|
619 participants
n=99 Participants
|
|
Oral Contraceptive Use History
Prior User
|
1408 participants
n=99 Participants
|
|
Smoking Status
Current Smoker
|
602 participants
n=99 Participants
|
|
Smoking Status
Former Smoker
|
636 participants
n=99 Participants
|
|
Smoking Status
Never Smoked
|
2359 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to year 1Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
Outcome measures
| Measure |
DR-103: Total
n=9217 Treatment cycles
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=7633 Treatment cycles
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=1584 Treatment cycles
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
|
2.82 pregnancies / 100 woman years exposure
Interval 2.1787 to 3.592
|
2.46 pregnancies / 100 woman years exposure
Interval 1.8111 to 3.2719
|
4.54 pregnancies / 100 woman years exposure
Interval 2.6963 to 7.1601
|
PRIMARY outcome
Timeframe: Day 1 up to year 1Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods including condoms were used.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
Outcome measures
| Measure |
DR-103: Total
n=2606 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=2149 Participants
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=457 Participants
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
|
3.25 pregnancies / 100 woman years exposure
Interval 2.5101 to 4.1372
|
2.83 pregnancies / 100 woman years exposure
Interval 2.0793 to 3.7556
|
5.32 pregnancies / 100 woman years exposure
Interval 3.1636 to 8.384
|
PRIMARY outcome
Timeframe: Day 1 up to year 1Population: 'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
Outcome measures
| Measure |
DR-103: Total
n=2505 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=2067 Participants
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=438 Participants
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
|
3.71 pregnancies / 100 woman years exposure
Interval 2.8629 to 4.7173
|
3.23 pregnancies / 100 woman years exposure
Interval 2.3742 to 4.2869
|
6.04 pregnancies / 100 woman years exposure
Interval 3.5894 to 9.5044
|
PRIMARY outcome
Timeframe: Day 1 up to year 1Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles)
Outcome measures
| Measure |
DR-103: Total
n=30785 Treatment cycles
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=25487 Treatment cycles
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=5298 Treatment cycles
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
|
2.74 pregnancies / 100 woman years exposure
Interval 2.1189 to 3.4975
|
2.40 pregnancies / 100 woman years exposure
Interval 1.7618 to 3.1869
|
4.42 pregnancies / 100 woman years exposure
Interval 2.6192 to 6.9735
|
PRIMARY outcome
Timeframe: Day 1 up to year 1Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods including condoms were used.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles)
Outcome measures
| Measure |
DR-103: Total
n=2972 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=2436 Participants
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=536 Participants
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
|
2.92 pregnancies / 100 woman years exposure
Interval 2.2558 to 3.7234
|
2.55 pregnancies / 100 woman years exposure
Interval 1.8745 to 3.3905
|
4.72 pregnancies / 100 woman years exposure
Interval 2.7973 to 7.4467
|
PRIMARY outcome
Timeframe: Day 1 up to year 1Population: 'Compliant-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles)
Outcome measures
| Measure |
DR-103: Total
n=2941 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=2531 Participants
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=531 Participants
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
|
3.07 pregnancies / 100 woman years exposure
Interval 2.3692 to 3.9105
|
2.68 pregnancies / 100 woman years exposure
Interval 1.9696 to 3.5625
|
4.94 pregnancies / 100 woman years exposure
Interval 2.9315 to 7.8034
|
PRIMARY outcome
Timeframe: Day 1 up to 13 monthsPopulation: Safety population of treated participants
The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date. Relationship to study drug was assessed by the investigator. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention.
Outcome measures
| Measure |
DR-103: Total
n=3597 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
Summary of Participants With Treatment-emergent Adverse Events
Treatment-emergent AEs (TEAEs)
|
2605 participants
|
—
|
—
|
|
Summary of Participants With Treatment-emergent Adverse Events
Treatment-related AEs
|
1086 participants
|
—
|
—
|
|
Summary of Participants With Treatment-emergent Adverse Events
Serious AEs
|
58 participants
|
—
|
—
|
|
Summary of Participants With Treatment-emergent Adverse Events
TEAEs leading to discontinuation
|
463 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to year 1Population: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.
Outcome measures
| Measure |
DR-103: Total
n=2769 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=2276 Participants
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=493 Participants
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 4
|
0.0272 pregnancies / cumulative exposure
Interval 0.0213 to 0.0346
|
0.0239 pregnancies / cumulative exposure
Interval 0.0179 to 0.0317
|
0.0429 pregnancies / cumulative exposure
Interval 0.027 to 0.0676
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 1
|
0.0074 pregnancies / cumulative exposure
Interval 0.0048 to 0.0113
|
0.0060 pregnancies / cumulative exposure
Interval 0.0035 to 0.0101
|
0.0139 pregnancies / cumulative exposure
Interval 0.0066 to 0.0289
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 2
|
0.0134 pregnancies / cumulative exposure
Interval 0.0097 to 0.0186
|
0.0114 pregnancies / cumulative exposure
Interval 0.0077 to 0.0168
|
0.0231 pregnancies / cumulative exposure
Interval 0.0129 to 0.0415
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 3
|
0.0212 pregnancies / cumulative exposure
Interval 0.0162 to 0.0277
|
0.0185 pregnancies / cumulative exposure
Interval 0.0135 to 0.0254
|
0.0339 pregnancies / cumulative exposure
Interval 0.0205 to 0.0558
|
SECONDARY outcome
Timeframe: Day 1 up to year 1Population: 'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.
Outcome measures
| Measure |
DR-103: Total
n=2505 Participants
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
DR-103: <90 kg Subpopulation
n=2067 Participants
Subpopulation of the total participants who weighed \<90 kg during the screening visit.
|
DR-103: >=90kg Subpopulation
n=438 Participants
Subpopulation of the total participants who weighed \>=90 kg during the screening visit.
|
|---|---|---|---|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 2
|
0.0134 pregnancies / cumulative exposure
Interval 0.0083 to 0.0215
|
0.0116 pregnancies / cumulative exposure
Interval 0.0066 to 0.0204
|
0.0215 pregnancies / cumulative exposure
Interval 0.009 to 0.0511
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 3
|
0.0236 pregnancies / cumulative exposure
Interval 0.0162 to 0.0344
|
0.0203 pregnancies / cumulative exposure
Interval 0.0129 to 0.0317
|
0.0392 pregnancies / cumulative exposure
Interval 0.0196 to 0.0776
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 4
|
0.0291 pregnancies / cumulative exposure
Interval 0.0206 to 0.0412
|
0.0256 pregnancies / cumulative exposure
Interval 0.017 to 0.0385
|
0.0457 pregnancies / cumulative exposure
Interval 0.0238 to 0.0871
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 1
|
0.0080 pregnancies / cumulative exposure
Interval 0.0044 to 0.0144
|
0.0062 pregnancies / cumulative exposure
Interval 0.003 to 0.013
|
0.0164 pregnancies / cumulative exposure
Interval 0.0062 to 0.0431
|
Adverse Events
DR-103
Serious adverse events
| Measure |
DR-103
n=3597 participants at risk
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.08%
3/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.14%
5/3597 • Day 1 - one year and three weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
3/3597 • Day 1 - one year and three weeks
|
|
Nervous system disorders
Syncope
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Psychiatric disorders
Depression suicidal
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Psychiatric disorders
Depression
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.14%
5/3597 • Day 1 - one year and three weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Hepatitis C
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Viral infection
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Rectal abscess
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Appendicitis
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Urinary tract infection
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Nervous system disorders
Headache
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Psychiatric disorders
Mental status changes
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Pyelonephritis
|
0.06%
2/3597 • Day 1 - one year and three weeks
|
|
Psychiatric disorders
Drug dependence
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Salpingitis
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Reproductive system and breast disorders
Uterine inflammation
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Gastrointestinal disorders
Ileitis
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Helicobacter gastritis
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.03%
1/3597 • Day 1 - one year and three weeks
|
Other adverse events
| Measure |
DR-103
n=3597 participants at risk
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.5%
342/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
9.0%
323/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Sinusitis
|
6.8%
246/3597 • Day 1 - one year and three weeks
|
|
Infections and infestations
Urinary tract infection
|
5.9%
214/3597 • Day 1 - one year and three weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.0%
216/3597 • Day 1 - one year and three weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.2%
188/3597 • Day 1 - one year and three weeks
|
|
Gastrointestinal disorders
Nausea
|
6.7%
241/3597 • Day 1 - one year and three weeks
|
|
Nervous system disorders
Headache
|
11.7%
420/3597 • Day 1 - one year and three weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.4%
193/3597 • Day 1 - one year and three weeks
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the study and its results shall not be publicized or published in any form to cooperative publication without prior, written consent of sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
- Publication restrictions are in place
Restriction type: OTHER