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 | Biotech Hunter

Enrollment

604

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions

BACTERIAL VAGINOSISSigns and Symptoms to be Evaluated and Recorded IncludeVaginal Discharge Color, Odor, and ConsistencyVulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or SevereVulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe

Interventions

DRUG

clindamycin phosphate vaginal cream 2%

OTHER

placebo

vehicle used as placebo

Trial Locations (18)

32771

Akesis investigator site 17, Sanford

77011

Akesis investigator site 18, Houston

Unknown

Akesis Investigator site 5, Birmingham

Akesis Investigator site 12, La Mesa

Akesis investigator site 6, San Diego

Akesis Investigator site 1, Boynton Beach

Akesis investigator site 14, North Miami

Akesis investigator site 8, Sunrise

Akesis Investigator site 10, West Palm Beach

Akesis Investigator site 9, Roswell

Akesis Investigator site 15, Metairie

Akesis investigator site 16, Lawrenceville

Akesis investigator site 11, Port Jefferson

Akesis investigator site 13, Philadelphia

Akesis Investigator site 7, Jackson

Akesis investigator site 3, Santo Domingo

Akesis investigator site 4, Santo Domingo

Akesis Investigator site 2, Ponce