Trial Outcomes & Findings for Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy (NCT NCT02770365)
NCT ID: NCT02770365
Last Updated: 2021-11-02
Results Overview
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH \< 5.0 with a change from Visit 1 of at least 0.5.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
695 participants
Primary outcome timeframe
Day 8
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Test Product
estradiol cream
estrace cream (Perrigo)
|
Reference Product
estradiol cream
estrace cream (Reference)
|
Placebo Product
Placebo cream
Placebo cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
277
|
279
|
139
|
|
Overall Study
COMPLETED
|
272
|
275
|
139
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Baseline characteristics by cohort
| Measure |
Test Product
n=275 Participants
estradiol cream
estrace cream (Perrigo)
|
Reference Product
n=277 Participants
estradiol cream
estrace cream (Reference)
|
Placebo Product
n=139 Participants
Placebo cream
Placebo cream
|
Total
n=691 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 6.35 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 6.31 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 6.06 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 6.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=5 Participants
|
277 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
691 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
220 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
548 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
233 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
582 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: Per protocol population
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH \< 5.0 with a change from Visit 1 of at least 0.5.
Outcome measures
| Measure |
Test Product
n=228 Participants
estradiol cream
estrace cream (Perrigo)
|
Reference Product
n=231 Participants
estradiol cream
estrace cream (Reference)
|
Placebo Product
n=121 Participants
Placebo cream
Placebo cream
|
|---|---|---|---|
|
Percentage of Subjects Identified as Responders
|
36.8 percentage of responders
|
32.0 percentage of responders
|
0.8 percentage of responders
|
SECONDARY outcome
Timeframe: Day 8Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
Outcome measures
| Measure |
Test Product
n=217 Participants
estradiol cream
estrace cream (Perrigo)
|
Reference Product
n=214 Participants
estradiol cream
estrace cream (Reference)
|
Placebo Product
Placebo cream
Placebo cream
|
|---|---|---|---|
|
Most Bothersome Symptom
|
116 Participants
|
123 Participants
|
—
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's cannot disclose trial results under any circumstances.
- Publication restrictions are in place
Restriction type: OTHER