Trial Outcomes & Findings for Phase 2B/3 Double-blinded Placebo-controlled (NCT NCT03107377)
NCT ID: NCT03107377
Last Updated: 2020-08-12
Results Overview
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
860 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-08-12
Participant Flow
Participant milestones
| Measure |
EVO100
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Overall Study
STARTED
|
426
|
434
|
|
Overall Study
COMPLETED
|
335
|
335
|
|
Overall Study
NOT COMPLETED
|
91
|
99
|
Reasons for withdrawal
| Measure |
EVO100
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Protocol Violation
|
9
|
12
|
|
Overall Study
Physician Decision
|
3
|
6
|
|
Overall Study
Pregnancy
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
16
|
22
|
|
Overall Study
Lost to Follow-up
|
37
|
34
|
|
Overall Study
Other reason not specified
|
16
|
15
|
Baseline Characteristics
Phase 2B/3 Double-blinded Placebo-controlled
Baseline characteristics by cohort
| Measure |
EVO100
n=426 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100l: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=434 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
Total
n=860 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
426 Participants
n=99 Participants
|
434 Participants
n=107 Participants
|
860 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
27.82 years
STANDARD_DEVIATION 7.112 • n=99 Participants
|
27.53 years
STANDARD_DEVIATION 6.722 • n=107 Participants
|
27.68 years
STANDARD_DEVIATION 6.916 • n=206 Participants
|
|
Sex: Female, Male
Female
|
426 Participants
n=99 Participants
|
434 Participants
n=107 Participants
|
860 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
135 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
291 Participants
n=99 Participants
|
286 Participants
n=107 Participants
|
577 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
185 Participants
n=99 Participants
|
173 Participants
n=107 Participants
|
358 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=99 Participants
|
239 Participants
n=107 Participants
|
467 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
426 participants
n=99 Participants
|
434 participants
n=107 Participants
|
860 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: mITT Population - All CT Analysis Eligible Subjects
Proportion of subjects who experience urogenital CT infection during the study intervention period (incident infection of CT).
Outcome measures
| Measure |
EVO100
n=289 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=290 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Urogenital CT Infection
|
14 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: mITT Population - All GC Analysis Eligible Subjects
Proportion of subjects who experience urogenital GC infection during the study intervention period (incident infection of GC).
Outcome measures
| Measure |
EVO100
n=280 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=277 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Urogenital GC Infection
|
2 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: mITT population
Summary of Coital Events during treatment
Outcome measures
| Measure |
EVO100
n=364 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=383 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Compliance With EVO100 and Sensitivity Analyses (Part I)
|
15.7 Coital Events
Standard Deviation 14.38
|
16.3 Coital Events
Standard Deviation 15.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Subject Satisfaction by Visit (mITT population)
The proportion of subjects who experienced at least one CT infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates.
Outcome measures
| Measure |
EVO100
n=273 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=267 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Subject Satisfaction With Product
Very satisfied
|
113 Participants
|
119 Participants
|
|
Subject Satisfaction With Product
Satisfied
|
128 Participants
|
121 Participants
|
|
Subject Satisfaction With Product
Somewhat Satisfied
|
26 Participants
|
24 Participants
|
|
Subject Satisfaction With Product
Somewhat dissatisfied
|
5 Participants
|
3 Participants
|
|
Subject Satisfaction With Product
Dissatisfied
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Subjects sexual satisfaction by Visit - mITT population
The proportion of subjects who experienced at least one GC infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates.
Outcome measures
| Measure |
EVO100
n=273 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=267 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Sexual Satisfaction
My sex life is a lot better than before
|
65 Participants
|
53 Participants
|
|
Sexual Satisfaction
My sex life is a little better than before
|
75 Participants
|
73 Participants
|
|
Sexual Satisfaction
My sex life is no different than before
|
124 Participants
|
137 Participants
|
|
Sexual Satisfaction
My sex life is a little worse than before
|
8 Participants
|
4 Participants
|
|
Sexual Satisfaction
My sex life is a lot worse than before
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: mITT Population - All CT Analysis Eligible Subjects
The proportion of subjects who experienced at least one CT infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates.
Outcome measures
| Measure |
EVO100
n=287 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=290 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Compliance With EVO100 and Sensitivity Analyses
of subjects w/ CT infection & >=20% adherence
|
17 Participants
|
13 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
of subjects w/ CT infection & >=40% adherence
|
19 Participants
|
24 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects w/ CT infection & 0% adherence
|
6 Participants
|
6 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
of subjects w/ CT infection & >0% <20% adherence
|
10 Participants
|
7 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
of subjects w/ CT infection & >=60% adhere
|
41 Participants
|
32 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
of subjects w/ CT infection & >=80% adhere
|
108 Participants
|
125 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
of subjects w/ CT infection & =100% adhere
|
86 Participants
|
83 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: mITT Population - All GC Analysis Eligible Subjects
The proportion of subjects who experienced at least one GC infection during the study Intervention Period was summarized by treatment group using the mITT population and subject adherence rates.
Outcome measures
| Measure |
EVO100
n=279 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=277 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects w/ GC infection & >0% <20% adherence
|
9 Participants
|
7 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects with GC infection & >=20% adherence
|
15 Participants
|
12 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects with GC infection & >=40% adherence
|
17 Participants
|
23 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects with GC infection & >=60% adh
|
40 Participants
|
36 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects with GC infection & >=80% adherence
|
106 Participants
|
123 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects with GC infection & =100% adherence
|
87 Participants
|
70 Participants
|
|
Compliance With EVO100 and Sensitivity Analyses
# of subjects with GC infection & 0% adherence
|
5 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: mITT population
Summary of number of applicators used via eDiary
Outcome measures
| Measure |
EVO100
n=360 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=377 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Compliance With EVO100 and Sensitivity Analyses (Part II)
|
13.0 Number of Applicators
Standard Deviation 12.95
|
13.5 Number of Applicators
Standard Deviation 15.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: mITT population
Study product adherence
Outcome measures
| Measure |
EVO100
n=360 Participants
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=377 Participants
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Compliance With EVO100 and Sensitivity Analyses (Part III)
|
78.9 % of sex acts where study product used
Standard Deviation 27.14
|
78.3 % of sex acts where study product used
Standard Deviation 27.78
|
Adverse Events
EVO100
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVO100
n=376 participants at risk
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=388 participants at risk
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.27%
1/376 • Number of events 1 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
0.00%
0/388 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.27%
1/376 • Number of events 1 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
0.00%
0/388 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/376 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
0.26%
1/388 • Number of events 1 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/376 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
0.26%
1/388 • Number of events 1 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/376 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
0.26%
1/388 • Number of events 1 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
Other adverse events
| Measure |
EVO100
n=376 participants at risk
A pH-buffering, acidity-maintaining gel (pH 3.5), containing three active compounds: lactic acid, citric acid, potassium bitartrate. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
EVO100: 5 g dose applied up to 1 hour prior to coitus
|
Placebo
n=388 participants at risk
An isotonic, non-buffering gel, pH adjusted to 4.5, containing 2.7% hydroxyethylcellulose, sorbic acid, sodium hydroxide, sodium chloride and purified water. 5 g intravaginally applied at least one hour prior to vaginal intercourse.
Placebo: 5 g dose applied up to 1 hour prior to coitus
|
|---|---|---|
|
Infections and infestations
Bacterial Vaginosis
|
2.9%
11/376 • Number of events 11 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
4.6%
18/388 • Number of events 18 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Infections and infestations
Urinary tract infections
|
3.2%
12/376 • Number of events 12 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
2.6%
10/388 • Number of events 10 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
5.1%
19/376 • Number of events 19 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
2.1%
8/388 • Number of events 8 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
3.2%
12/376 • Number of events 12 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
2.6%
10/388 • Number of events 10 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
2.1%
8/376 • Number of events 8 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
0.00%
0/388 • 20 weeks
For the 860 subjects randomized into the study, 764 had documented use of study product and were a part of the safety population/analyzed for safety purposes. Amongst these 764 subjects, no deaths were reported during the course of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place