Trial · NCT02210689
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
NCT02210689, Phase 3, Completed, Actavis Inc.; results first posted 2019-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT02210689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02210689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT02210689
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 604 participants, actual
- Lead sponsor
- Actavis Inc.
- Conditions
BACTERIAL 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
- Interventions
- clindamycin phosphate vaginal cream 2%, placebo
- First posted
- 2014-08-07
- Last updated
- 2020-01-28
- Results first posted
- 2019-12-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30). | 22 to 30 days | Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows: 1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle, 2. The whiff test is negative for any amine ("fishy") odor, 3. The saline wet mount is negative for clue cells, 4. Vaginal fluid pH is \< 4.7, using pH paper that measures from 3.6 to 6.1. A Bacteriological cure is defined as a Nugent score \< 4. The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field: 1. Lactobacillus: large gram positive rods, 2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, 3. Mobiluncus spp.: thin, curved Gram variable rods |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30). | 22 to 30 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30). | Test Product | 36 | Participants | ||
| Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30). | Reference Product | 34 | Participants | ||
| Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30). | Placebo | 9 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Generic Clindamycin Phosphate Vaginal Cream 2% | 242 | |
| Overall Study | STARTED | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 240 | |
| Overall Study | STARTED | Vehicle Cream | 122 | |
| Overall Study | Safety Population | Generic Clindamycin Phosphate Vaginal Cream 2% | 233 | |
| Overall Study | Safety Population | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 236 | |
| Overall Study | Safety Population | Vehicle Cream | 122 | |
| Overall Study | mITT Population | Generic Clindamycin Phosphate Vaginal Cream 2% | 199 | |
| Overall Study | mITT Population | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 207 | |
| Overall Study | mITT Population | Vehicle Cream | 107 | |
| Overall Study | PP Population | Generic Clindamycin Phosphate Vaginal Cream 2% | 164 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events246
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye Disorder | Eye disorders | Generic Clindamycin Phosphate Vaginal Cream 2% | 1 | 233 | |
| other | Eye Disorder | Eye disorders | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 0 | 236 | |
| other | Eye Disorder | Eye disorders | Vehicle Cream | 0 | 122 | |
| other | Eye Irritation | Eye disorders | Generic Clindamycin Phosphate Vaginal Cream 2% | 0 | 233 | |
| other | Eye Irritation | Eye disorders | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 1 | 236 | |
| other | Eye Irritation | Eye disorders | Vehicle Cream | 0 | 122 | |
| other | Eye pruritus | Eye disorders | Generic Clindamycin Phosphate Vaginal Cream 2% | 1 | 233 | |
| other | Eye pruritus | Eye disorders | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 0 | 236 | |
| other | Eye pruritus | Eye disorders | Vehicle Cream | 0 | 122 | |
| other | Abdominal distension | Gastrointestinal disorders | Generic Clindamycin Phosphate Vaginal Cream 2% | 2 | 233 |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic Clindamycin Phosphate Vaginal Cream 2% | 0 | 233 |
| Total, all-cause mortality | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 0 | 236 |
| Total, all-cause mortality | Vehicle Cream | 0 | 122 |
| Total, other adverse events | Generic Clindamycin Phosphate Vaginal Cream 2% | 65 | 233 |
| Total, other adverse events | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 79 | 236 |
| Total, other adverse events | Vehicle Cream | 45 | 122 |
| Total, serious adverse events | Generic Clindamycin Phosphate Vaginal Cream 2% | 0 | 233 |
| Total, serious adverse events | Clindesse (Clindamycin Phosphate Vaginal Cream 2%) | 0 | 236 |
| Total, serious adverse events | Vehicle Cream | 0 | 122 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02210689
GET https://conductscience.org/api/trials/v1/NCT02210689/events?page=2