Trial Outcomes & Findings for Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms. (NCT NCT01070979)
NCT ID: NCT01070979
Last Updated: 2013-04-22
Results Overview
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
249 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2013-04-22
Participant Flow
Enrollment of postmenopausal women for relief of hot flushes and urogenital symptoms beginning Feb '03 at 33 sites in the US.
Discontinue estrogen/hormone therapy prior to enrollment
Participant milestones
| Measure |
Estradiol Acetate (E3A)
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
85
|
85
|
|
Overall Study
COMPLETED
|
68
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
13
|
Reasons for withdrawal
| Measure |
Estradiol Acetate (E3A)
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
6
|
|
Overall Study
Surgery, moving, personal, abn. labs
|
4
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
|
Overall Study
No study drug taken
|
0
|
1
|
0
|
Baseline Characteristics
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
Baseline characteristics by cohort
| Measure |
Estradiol Acetate (E3A)
n=79 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=85 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=85 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
52.2 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
52.3 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
52.8 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
249 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=99 Participants
|
85 participants
n=107 Participants
|
85 participants
n=206 Participants
|
249 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
|
-54.1 Change in Hot Flush Count
Standard Error 4.5
|
-62.0 Change in Hot Flush Count
Standard Error 4.5 • Interval 0.721 to 1.048
|
-54.5 Change in Hot Flush Count
Standard Error 4.3 • Interval 0.833 to 1.178
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
|
-63.6 Change in Hot Flush Count
Standard Error 4.8
|
-72.2 Change in Hot Flush Count
Standard Error 4.7
|
-67.2 Change in Hot Flush Count
Standard Error 4.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
|
-0.53 Change in Score
Standard Error 0.106
|
-0.51 Change in Score
Standard Error 0.106
|
-0.59 Change in Score
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
|
-1.05 Change in Score
Standard Error 0.127
|
-1.34 Change in Score
Standard Error 0.125
|
-1.17 Change in Score
Standard Error 0.122
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
|
-1.89 Change in Score
Standard Error 0.413
|
-2.26 Change in Score
Standard Error 0.407
|
-1.96 Change in Score
Standard Error 0.398
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
|
-1.96 Change in Score
Standard Error 0.432
|
-2.58 Change in Score
Standard Error 0.425
|
-2.42 Change in Score
Standard Error 0.416
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Outcome measures
| Measure |
Estradiol Acetate (E3A)
n=77 Participants
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=80 Participants
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=84 Participants
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
|
-2.49 Change in Score
Standard Error 0.437
|
-2.59 Change in Score
Standard Error 0.431
|
-2.52 Change in Score
Standard Error 0.422
|
Adverse Events
Estradiol Acetate (E3A)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Estradiol
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Conjugated Equine Estrogens (CEE)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Estradiol Acetate (E3A)
n=79 participants at risk
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=84 participants at risk
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=85 participants at risk
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Reproductive system and breast disorders
metrorrhagia
|
0.00%
0/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
1.2%
1/84 • Number of events 1 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
0.00%
0/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
Other adverse events
| Measure |
Estradiol Acetate (E3A)
n=79 participants at risk
1 tablet daily containing 0.9 mg estradiol acetate
|
Estradiol
n=84 participants at risk
1 tablet daily containing 1 mg estradiol
|
Conjugated Equine Estrogens (CEE)
n=85 participants at risk
1 tablet daily containing 0.625 mg conjugated equine estrogen
|
|---|---|---|---|
|
Reproductive system and breast disorders
Breast Tenderness
|
2.5%
2/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
6.0%
5/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
5.9%
5/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
4/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
1.2%
1/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
2.4%
2/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Nervous system disorders
Headache
|
3.8%
3/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
6.0%
5/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
7.1%
6/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.5%
2/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
3.6%
3/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
4.7%
4/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Gastrointestinal disorders
Abdominal Distention
|
1.3%
1/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
4.8%
4/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
2.4%
2/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Infections and infestations
Vaginosis Fungal
|
0.00%
0/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
1.2%
1/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
3.5%
3/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Investigations
Weight Increased
|
1.3%
1/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
1.2%
1/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
3.5%
3/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
2/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
2.4%
2/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
3.5%
3/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Nervous system disorders
Nasopharyngitis
|
1.3%
1/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
3.6%
3/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
0.00%
0/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
|
Psychiatric disorders
Anxiety
|
3.8%
3/79 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
0.00%
0/84 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
2.4%
2/85 • 7 months
February 2003 thru September 2003, One subject randomized to estradiol group never took any study drug therefore not included in AE assessment.
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60