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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2020-01-28

Study results available
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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.

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

DRUG

clindamycin phosphate vaginal cream 2%

OTHER

placebo

vehicle used as placebo

Sponsors & Collaborators

  • Watson Laboratories, Inc.

    collaborator INDUSTRY

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • nageshwar r thudi, Ph.D., CCRP · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States
  • Dominican Republic
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02210689 on ClinicalTrials.gov