At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 604 enrolled
Drug / intervention
clindamycin phosphate vaginal cream 2% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women
In Brief
A Phase 3 clinical trial evaluating clindamycin phosphate vaginal cream 2% and placebo for BACTERIAL VAGINOSIS and 4 related conditions. Completed, enrolled 604 participants across 18 sites in 3 countries.
Detailed Summary
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the treatment of bacterial vaginosis in non-pregnant women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBACTERIAL VAGINOSIS, Signs and Symptoms to be Evaluated and Recorded Include, Vaginal Discharge Color, Odor, and Consistency, Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe, Vulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe
CountriesDominican Republic, Puerto Rico, United States
CollaboratorsWatson Laboratories, Inc.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedAug 2014
Primary CompletionOct 2014
Study CompletionDec 2014
TodayJul 2026
First PostedAug 7, 2014
Enrollment StartJan 1, 2014
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.9 years ago
Interventions
clindamycin phosphate vaginal cream 2%drug
placeboother
vehicle used as placebo