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NCT02210689 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Bacterial Vaginosis and Signs and Symptoms to be Evaluated and Recorded Include, sponsored by Actavis.

Completed
Registry status
Phase 3
Development phase
604
Enrollment target
18
Study locations

NCT02210689: Completed Phase 3 study of Bacterial Vaginosis and Signs and Symptoms to be Evaluated and Recorded Include, sponsored by Actavis.

NCT02210689 is a Phase 3 study of Bacterial Vaginosis and Signs and Symptoms to be Evaluated and Recorded Include that has completed, run by Actavis. The registered enrollment target is 604 participants, above the 298-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (103% higher). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02210689, a Phase 3 study of Bacterial Vaginosis and Signs and Symptoms to be Evaluated and Recorded Include, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 3
Development phase
604 participants
Enrollment target
18
Study locations

Study 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.

Primary Outcome

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 Bacteriolo

Conditions Studied

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

  • OTHER placebo
  • DRUG clindamycin phosphate vaginal cream 2%

Study Locations (18)

Florida

  • Akesis Investigator site 1 - Boynton Beach
  • Akesis investigator site 14 - North Miami
  • Akesis investigator site 17 - Sanford
  • Akesis investigator site 8 - Sunrise
  • Akesis Investigator site 10 - West Palm Beach

California

  • Akesis Investigator site 12 - La Mesa
  • Akesis investigator site 6 - San Diego

Republica Dominicana

  • Akesis investigator site 3 - Santo Domingo
  • Akesis investigator site 4 - Santo Domingo

Alabama

  • Akesis Investigator site 5 - Birmingham

Georgia

  • Akesis Investigator site 9 - Roswell

Louisiana

  • Akesis Investigator site 15 - Metairie

New Jersey

  • Akesis investigator site 16 - Lawrenceville

New York

  • Akesis investigator site 11 - Port Jefferson

Trial Details

FieldValue
Enrollment Target 604 participants
Start Date 2014-01
Est. Completion 2014-12
Phase Phase 3
Actavis

79 total trials

What the finished NCT02210689 record still lists

NCT02210689 is an interventional study that assigns participants to a tested intervention. The registered 604 participants enrollment target is mid-sized for trials with a published cap, above the 298-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (103% higher).

The record links to 5 conditions, with Bacterial Vaginosis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT02210689 lists 18 locations in 12 states (Florida, California, Republica Dominicana).

Frequently Asked Questions

What is clinical trial NCT02210689 about?

NCT02210689 is a clinical study titled "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". 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 bacteri...

What is the current status of trial NCT02210689?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 604 participants. The study started on 2014-01. Estimated completion is 2014-12.

What conditions does trial NCT02210689 study?

This clinical trial studies the following 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.

What interventions are being tested in trial NCT02210689?

The interventions under investigation include: placebo (OTHER), clindamycin phosphate vaginal cream 2% (DRUG).

Who is sponsoring clinical trial NCT02210689?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02210689 being conducted?

This trial has 18 study locations across Alabama, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Bacterial Vaginosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02210689's enrollment target sits among peer trials

604 3rd of 15 higher than 13 of 15 other Bacterial Vaginosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bacterial Vaginosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02210689, the US trial registry maintained by the National Library of Medicine. NCT02210689 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.