Trial Outcomes & Findings for A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis (NCT NCT02995694)
NCT ID: NCT02995694
Last Updated: 2021-12-01
Results Overview
Number of patients in PP population identified as responders at end of the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
535 participants
Primary outcome timeframe
Day 8
Results posted on
2021-12-01
Participant Flow
Participant milestones
| Measure |
Test
Estradiol Vaginal Cream
Estradiol: Estradiol Vaginal Cream
|
Reference.
Estrace Vaginal Cream
Reference: Estrace Vaginal Cream
|
Placebos
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
215
|
211
|
109
|
|
Overall Study
COMPLETED
|
181
|
183
|
94
|
|
Overall Study
NOT COMPLETED
|
34
|
28
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
Baseline characteristics by cohort
| Measure |
Estradiol Vaginal Cream
n=181 Participants
Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)
|
Estrace Vaginal Cream
n=183 Participants
Estrace Vaginal Cream, 0.01%, administered once daily for 7 days. Estrace Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)
|
Placebo
n=94 Participants
Placebo Cream, administered once daily for 7 days. Placebo Cream, (1 x 2 g for 7 days)
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
167 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
428 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Continuous
|
59.0 years
n=5 Participants
|
59.4 years
n=7 Participants
|
59.9 years
n=5 Participants
|
59.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
458 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
|
62 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
299 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
405 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
|
Region of Enrollment
United States
|
181 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
458 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 8Number of patients in PP population identified as responders at end of the study.
Outcome measures
| Measure |
Test
n=181 Participants
Estradiol Vaginal Cream
Estradiol: Estradiol Vaginal Cream
|
Reference.
n=183 Participants
Estrace Vaginal Cream
Reference: Estrace Vaginal Cream
|
Placebos
n=94 Participants
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream
|
|---|---|---|---|
|
Vaginal Cytology
|
29 participants
|
19 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 8Number of participants with the most bothersome vulvar and/or vaginal atrophy symptom treatment success at end of study. A "Treatment Success" was defined as a score of 0 or 1 at Day 8 (maximum Day 10) for the symptom identified at baseline as the most bothersome. This evaluation was based on patient self-assessed symptoms of VVA on a scale of 0 to 3 where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Outcome measures
| Measure |
Test
n=181 Participants
Estradiol Vaginal Cream
Estradiol: Estradiol Vaginal Cream
|
Reference.
n=183 Participants
Estrace Vaginal Cream
Reference: Estrace Vaginal Cream
|
Placebos
n=94 Participants
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream
|
|---|---|---|---|
|
Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy
|
115 Participants
|
114 Participants
|
0 Participants
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
Reference.
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
Placebos
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test
n=215 participants at risk
Estradiol Vaginal Cream
Estradiol: Estradiol Vaginal Cream
|
Reference.
n=211 participants at risk
Estrace Vaginal Cream
Reference: Estrace Vaginal Cream
|
Placebos
n=109 participants at risk
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Placebos: Placebo with no active pharmaceutical ingredients. Topical vaginal cream
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
16.7%
36/215 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
17.1%
36/211 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
18.3%
20/109 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
16.7%
36/215 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
17.5%
37/211 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
4.6%
5/109 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
|
Nervous system disorders
Nervous System Disorders
|
6.0%
13/215 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
9.0%
19/211 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
4.6%
5/109 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
|
Psychiatric disorders
Psychiatric disorders
|
1.4%
3/215 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
1.4%
3/211 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
0.00%
0/109 • 9 months
There was one SAE, a death, reported for a subject during screening who had not yet been randomized into the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60