Trial Outcomes & Findings for Suppression Of Bacterial Vaginosis (BV) [SUBVert] (NCT NCT03930745)
NCT ID: NCT03930745
Last Updated: 2023-02-22
Results Overview
Recurrent bacterial vaginosis (RBV) was defined as the presence of at least three out of the following four Amsel criteria: positive KOH whiff test, homogeneous discharge characteristic of BV, clue cells comprising at least 20% of vaginal squamous epithelial cells, and vaginal pH \> 4.5. Participants who had post-baseline efficacy results but were lost to follow-up before study completion were considered "treatment failures" and counted toward the number of participants with recurrence of BV.
COMPLETED
PHASE2
81 participants
Day 1 through Day 91
2023-02-22
Participant Flow
Participants were adult females 18-55 years of age with a history of recurrent bacterial vaginosis. Participants were recruited from United States health clinics and enrolled between 09SEP2019 and 20SEP2021
Participant milestones
| Measure |
TOL-463 Vaginal Insert
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
TOL-463 Vaginal Insert: Non-azole vaginal anti-infective drug candidate designed as a dual-indication therapy for bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). Hydrophilic melt insert supplied in 2.0 cc/g low density polyethylene (LDPE) + polyvinyl chloride (PVC) plastic unit-dose insert molds with ten vaginal applicators.
|
Placebo
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
Placebo: Matching placebo vaginal insert supplied in 2.0 cc/g low density polyethylene (LDPE) + polyvinyl chloride (PVC) plastic unit-dose insert molds with ten vaginal applicators.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
TOL-463 Vaginal Insert
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
TOL-463 Vaginal Insert: Non-azole vaginal anti-infective drug candidate designed as a dual-indication therapy for bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). Hydrophilic melt insert supplied in 2.0 cc/g low density polyethylene (LDPE) + polyvinyl chloride (PVC) plastic unit-dose insert molds with ten vaginal applicators.
|
Placebo
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
Placebo: Matching placebo vaginal insert supplied in 2.0 cc/g low density polyethylene (LDPE) + polyvinyl chloride (PVC) plastic unit-dose insert molds with ten vaginal applicators.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
COVID-19 Shelter in Place Order
|
3
|
5
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
Baseline characteristics by cohort
| Measure |
TOL-463 Vaginal Insert
n=40 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=41 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Number of BV Occurrences in Past 12 Months Prior to Screening
|
5.3 occurrences
STANDARD_DEVIATION 2.5 • n=5 Participants
|
4.9 occurrences
STANDARD_DEVIATION 2.7 • n=7 Participants
|
5.1 occurrences
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Culture Confirmed Vulvovaginal Candidiasis (VVC) Status at Baseline
Positive
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Culture Confirmed Vulvovaginal Candidiasis (VVC) Status at Baseline
Negative
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Culture Confirmed Vulvovaginal Candidiasis (VVC) Status at Baseline
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 91Population: The modified intent-to-treat (mITT) population includes all randomized participants with negative STI results at screening and, for participants 21 years and older, either a normal or atypical squamous cells of undetermined significance (ASCUS) HPV-negative Pap test performed at screening or within the past 3 years. This analysis includes all participants in the mITT population except those with no post-baseline efficacy data available.
Recurrent bacterial vaginosis (RBV) was defined as the presence of at least three out of the following four Amsel criteria: positive KOH whiff test, homogeneous discharge characteristic of BV, clue cells comprising at least 20% of vaginal squamous epithelial cells, and vaginal pH \> 4.5. Participants who had post-baseline efficacy results but were lost to follow-up before study completion were considered "treatment failures" and counted toward the number of participants with recurrence of BV.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=31 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=33 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Proportion of Participants With Recurrent Bacterial Vaginosis (RBV) by Visit 4, as Defined by Presence of at Least 3 Amsel Criteria
|
0.581 proportion of participants
Interval 0.408 to 0.736
|
0.697 proportion of participants
Interval 0.527 to 0.826
|
SECONDARY outcome
Timeframe: Day 1 through Day 91Population: The modified intent-to-treat (mITT) population includes all randomized participants with negative STI results at screening and, for participants 21 years and older, either a normal or atypical squamous cells of undetermined significance (ASCUS) HPV-negative Pap test performed at screening or within the past 3 years. This analysis includes all participants in the mITT population, excluding those with no post-baseline efficacy data available and those diagnosed with BV off-study.
Recurrent bacterial vaginosis (RBV) was defined as the presence of at least three out of the following four Amsel criteria: positive KOH whiff test, homogeneous discharge characteristic of BV, clue cells comprising at least 20% of vaginal squamous epithelial cells, and vaginal pH \> 4.5. Participants who had post-baseline efficacy results but were lost to follow-up before study completion were censored in secondary time-to-event analyses. Participants with off-study diagnosis of BV were excluded from secondary time-to-event analyses. The median time to BV recurrence was calculated as the first event time at which the Kaplan-Meier estimator drops to or below 0.5.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=30 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=32 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Time to Bacterial Vaginosis (BV) Recurrence, as Defined by Presence of at Least 3 Amsel Criteria
|
NA days
Interval 42.0 to
The median time to BV recurrence and upper limit of the confidence interval could not be estimated because fewer than 50% of participants in the TOL-463 Arm experienced on-study diagnosis of BV recurrence during the follow-up period.
|
46 days
Interval 16.0 to
The upper limit of the confidence interval could not be estimated because the median estimate of time to BV recurrence was also the maximum time to recurrence in the Placebo Arm during the follow-up period.
|
SECONDARY outcome
Timeframe: Assessed at Visit 1 (Day 1), Visit 2 (Window: Days 29-35), Visit 3 (Window: Days 57-63) and Visit 4 (Window: Days 85-91).Population: The modified intent-to-treat (mITT) population includes all randomized participants with negative STI results at screening and, for participants 21 years and older, either a normal or atypical squamous cells of undetermined significance (ASCUS) HPV-negative Pap test performed at screening or within the past 3 years. This analysis includes all participants in the mITT population with data available from the corresponding visit.
The BV symptoms evaluated for efficacy at each clinic visit included abnormal vaginal discharge and vaginal odor. Both symptoms were assessed by a clinician as either consistent with BV, not consistent with BV, or absent. Only symptoms deemed consistent with BV were reported as BV symptoms.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=40 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=41 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Abnormal Vaginal Discharge
Visit 1
|
0.025 proportion of participants
Interval 0.004 to 0.129
|
0.000 proportion of participants
Interval 0.0 to 0.086
|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Abnormal Vaginal Discharge
Visit 2
|
0.091 proportion of participants
Interval 0.031 to 0.236
|
0.114 proportion of participants
Interval 0.045 to 0.26
|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Abnormal Vaginal Discharge
Visit 3
|
0.056 proportion of participants
Interval 0.01 to 0.258
|
0.063 proportion of participants
Interval 0.011 to 0.283
|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Abnormal Vaginal Discharge
Visit 4
|
0.000 proportion of participants
Interval 0.0 to 0.215
|
0.000 proportion of participants
Interval 0.0 to 0.278
|
SECONDARY outcome
Timeframe: Assessed at Visit 1 (Day 1), Visit 2 (Window: Days 29-35), Visit 3 (Window: Days 57-63) and Visit 4 (Window: Days 85-91).Population: The modified intent-to-treat (mITT) population includes all randomized participants with negative STI results at screening and, for participants 21 years and older, either a normal or atypical squamous cells of undetermined significance (ASCUS) HPV-negative Pap test performed at screening or within the past 3 years. This analysis includes all participants in the mITT population with data available from the corresponding visit.
The BV symptoms evaluated for efficacy at each clinic visit included abnormal vaginal discharge and vaginal odor. Both symptoms were assessed by a clinician as either consistent with BV, not consistent with BV, or absent. Only symptoms deemed consistent with BV were reported as BV symptoms.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=40 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=41 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Vaginal Odor
Visit 1
|
0.025 proportion of participants
Interval 0.004 to 0.129
|
0.024 proportion of participants
Interval 0.004 to 0.126
|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Vaginal Odor
Visit 2
|
0.152 proportion of participants
Interval 0.067 to 0.309
|
0.143 proportion of participants
Interval 0.063 to 0.294
|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Vaginal Odor
Visit 3
|
0.056 proportion of participants
Interval 0.01 to 0.258
|
0.125 proportion of participants
Interval 0.035 to 0.36
|
|
Proportion of Participants Reporting Bacterial Vaginosis (BV) Symptoms - Vaginal Odor
Visit 4
|
0.000 proportion of participants
Interval 0.0 to 0.215
|
0.100 proportion of participants
Interval 0.018 to 0.404
|
SECONDARY outcome
Timeframe: Assessed at study completion (the visit at which the participant was diagnosed with BV, or Visit 4 for participants remaining BV suppressed). This may occur at Visit 2 (Window: Days 29-35), Visit 3 (Window: Days 57-63) or Visit 4 (Window: Days 85-91).Population: The modified intent-to-treat (mITT) population includes all randomized participants with negative STI results at screening and, for participants 21 years and older, either a normal or atypical squamous cells of undetermined significance (ASCUS) HPV-negative Pap test performed at screening or within the past 3 years. This analysis includes all participants in the mITT population who completed the satisfaction questionnaire.
The satisfaction questionnaire contained five questions assessing participant satisfaction with the study treatment. For questions regarding ease of use, frequency of use, and overall satisfaction, participants could respond on a scale ranging from "Extremely dissatisfied" to "Extremely satisfied." Participants who responded with "Somewhat satisfied" through "Extremely satisfied" were considered "Satisfied" with those categories. For the question regarding convenience of use, participants could respond on a scale ranging from "Extremely inconvenient" to "Extremely convenient." Participants who responded with "Somewhat convenient" through "Extremely convenient" were considered "Satisfied" with study treatment convenience. For the question of whether the participant would use the study treatment again, participants who responded with "Yes" were considered "Satisfied" with the study treatment.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=27 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=33 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Ease of use · Satisfied
|
25 Participants
|
28 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Ease of use · Not Satisfied
|
2 Participants
|
5 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Frequency of use · Satisfied
|
25 Participants
|
33 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Frequency of use · Not Satisfied
|
2 Participants
|
0 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Convenience of use · Satisfied
|
26 Participants
|
29 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Convenience of use · Not Satisfied
|
1 Participants
|
4 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Overall satisfaction · Satisfied
|
26 Participants
|
25 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Overall satisfaction · Not Satisfied
|
1 Participants
|
8 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Would use study treatment again · Satisfied
|
25 Participants
|
26 Participants
|
|
Number of Participants Satisfied With the Study Treatment as Assessed by Satisfaction Questionnaire Responses
Would use study treatment again · Not Satisfied
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 91Population: The Safety population includes all randomized participants who received at least one dose of study treatment. Participants with any evidence of dosing according to memory aid or study IP packaging return were included in the Safety population.
Safety was monitored throughout the study, including via participant reporting. Study clinicians assessed whether or not reported adverse events (AEs) were related to study treatment.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=33 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=37 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) Considered Product-related Following Initiation of Study Treatment
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 91Population: The Safety population includes all randomized participants who received at least one dose of study treatment. Participants with any evidence of dosing according to memory aid or study IP packaging return were included in the Safety population.
Assessment of vulvovaginal candidiasis (VVC) was performed by pelvic examination at baseline and at each follow-up visit. If clinical diagnosis of VVC was determined at any visit, then a confirmatory Candida culture was performed.
Outcome measures
| Measure |
TOL-463 Vaginal Insert
n=33 Participants
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=37 Participants
Placebo administered vaginally as a single 2 gram (g) unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Number of Participants With Culture Confirmed Secondary VVC Following Initiation of Study Treatment
|
0 Participants
|
3 Participants
|
Adverse Events
TOL-463 Vaginal Insert
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TOL-463 Vaginal Insert
n=40 participants at risk
TOL-463 Vaginal Insert administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
Placebo
n=41 participants at risk
Placebo administered vaginally as a single 2 gram unit dose twice a week with a minimum of a two-day duration in between doses for twelve weeks with the aid of a disposable applicator.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • Number of events 2 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
0.00%
0/41 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
2/40 • Number of events 2 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
0.00%
0/41 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.5%
3/40 • Number of events 3 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
4.9%
2/41 • Number of events 2 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
12.5%
5/40 • Number of events 5 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
7.3%
3/41 • Number of events 3 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
|
Reproductive system and breast disorders
Vulvovaginal Burning Sensation
|
5.0%
2/40 • Number of events 2 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
7.3%
3/41 • Number of events 3 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
|
Reproductive system and breast disorders
Vulvovaginal Discomfort
|
7.5%
3/40 • Number of events 3 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
2.4%
1/41 • Number of events 1 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
10.0%
4/40 • Number of events 6 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
9.8%
4/41 • Number of events 4 • Safety was monitored from Visit 1 (Day 1) through Visit 4 (Window: Days 85-91).
AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE. AEs were collected for all enrolled participants.
|
Additional Information
Jeanne Marrazzo, MD, MPH
University of Alabama at Birmingham School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place