Trial Outcomes & Findings for DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE) (NCT NCT04370548)
NCT ID: NCT04370548
Last Updated: 2022-12-08
Results Overview
Clinical cure is defined as: * Resolution of the abnormal vaginal discharge associated with BV; * Negative 10% KOH "whiff test;" and * Clue cells \< 20% of the total epithelial cells in the saline wet mount.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
307 participants
Primary outcome timeframe
Visit 3 Day 21-30 post randomization
Results posted on
2022-12-08
Participant Flow
Participant milestones
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
103
|
|
Overall Study
COMPLETED
|
190
|
100
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
Baseline characteristics by cohort
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=204 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=103 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
307 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
|
57 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
116 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
204 participants
n=5 Participants
|
103 participants
n=7 Participants
|
307 participants
n=5 Participants
|
|
BMI, Continuous
|
31.75 kg/m^2
STANDARD_DEVIATION 8.667 • n=5 Participants
|
30.84 kg/m^2
STANDARD_DEVIATION 8.183 • n=7 Participants
|
31.45 kg/m^2
STANDARD_DEVIATION 8.505 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3 Day 21-30 post randomizationPopulation: Clinical Cure of the mITT Population (missing data were treated as Treatment Failure)
Clinical cure is defined as: * Resolution of the abnormal vaginal discharge associated with BV; * Negative 10% KOH "whiff test;" and * Clue cells \< 20% of the total epithelial cells in the saline wet mount.
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=122 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=59 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Clinical Cure at the TOC Visit (Day 21-30).
|
86 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Visit 2 Day 7-14 post randomizationPopulation: mITT Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=122 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=59 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14).
|
93 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Visit 3 Day 21-30 post randomizationPopulation: mITT Population
Bacteriological cure is defined as a Nugent score \< 4
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=122 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=59 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30).
|
53 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Visit 2, Days 7-14 post randomizationPopulation: mITT population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=122 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=59 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14
|
50 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 3 Day 21-30 post randomizationPopulation: mITT Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=122 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=59 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30).
|
45 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Visit 2 Day 7-14 post randomizationPopulation: mITT Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=122 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=59 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14).
|
43 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 3, Days 21-30 post randomizationPopulation: Per Protocol (PP) Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=102 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=47 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Clinical Cure at the Test of Cure Visit (21-30)
|
79 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2, Days 7-14 post randomizationOutcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=102 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=47 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Clinical Cure at Interim Assessment Visit, Days 7-14, PP Population
|
83 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 3, Days 21-30 post randomizationPopulation: Per Protocol Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=102 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=47 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population
|
46 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2, Days 7-14 post randomizationPopulation: PP Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=102 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=47 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population
|
45 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 3, Days 21-30 post randomizationPopulation: PP Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=102 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=47 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Therapeutic Cure at Test of Cure Visit, Days 21-30; PP Population
|
41 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2, Days 7-14 post randomizationPopulation: PP Population
Outcome measures
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=102 Participants
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=47 Participants
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Number of Patients With Therapeutic Cure, Interim Assessment Visit, Days 7-14, PP Population
|
39 Participants
|
0 Participants
|
Adverse Events
Clindamycin Phosphate Vaginal Gel, 2%
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Placebo Vaginal Gel (Universal HEC Placebo Gel)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=203 participants at risk
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=103 participants at risk
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Reproductive system and breast disorders
Cervical dysplasia/High Grade Squamous Intraepithelial Lesion with features for invasion
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
Other adverse events
| Measure |
Clindamycin Phosphate Vaginal Gel, 2%
n=203 participants at risk
One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) will be applied intravaginally as a single dose within 1 day of randomization.
|
Placebo Vaginal Gel (Universal HEC Placebo Gel)
n=103 participants at risk
One full applicator (5 g) of placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
|
|---|---|---|
|
Infections and infestations
Vulvovaginal candidiasis
|
17.2%
35/203 • Number of events 37 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
3.9%
4/103 • Number of events 4 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.99%
2/203 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
1.9%
2/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhea
|
0.99%
2/203 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
General disorders
Pyrexia
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Bacterial Vaginosis
|
1.5%
3/203 • Number of events 3 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
2.9%
3/103 • Number of events 3 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
COVID-19
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Genital herpes
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Herpes zoster
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
1.9%
2/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Trichomoniasis
|
2.0%
4/203 • Number of events 4 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
1.9%
2/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
6/203 • Number of events 6 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
4.9%
5/103 • Number of events 5 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Investigations
Blood pressure incrased
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Nervous system disorders
Ageusia
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Nervous system disorders
Anosmia
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Nervous system disorders
Headache
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Nervous system disorders
Somnolence
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Cervical friability
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.5%
3/203 • Number of events 3 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.5%
5/203 • Number of events 5 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
3.9%
4/103 • Number of events 4 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
1.5%
3/203 • Number of events 3 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
1.9%
2/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.49%
1/203 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.99%
2/203 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.4%
9/203 • Number of events 10 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
1.9%
2/103 • Number of events 2 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/203 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.97%
1/103 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
|
Surgical and medical procedures
Tooth extraction
|
0.49%
1/203 • Number of events 1 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
0.00%
0/103 • Adverse Events were collected for the entire study duration, approximately 3.5 months.
There was one subject in the Clindamycin Phosphate Vaginal Gel, 2% group that withdrew from the study after randomization, but prior to dosing. This subject was not included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place