Vaginal Infection Clinical Trial
Official title:
A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Verified date | June 2011 |
Source | Graceway Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.
Status | Completed |
Enrollment | 255 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Females at least 18 years of age - In good general health - Confirmed current diagnosis of bacterial vaginosis (determined at study screening) - Negative pregnancy test (for women who are able to become pregnant) - Must abstain from sexual intercourse throughout the first 7 days of thes study - Must abstain from alcohol ingestion during the treatment period and for one day afterward - Must not use intra-vaginal products for the duration of the study Exclusion Criteria: - Pregnant, lactating, or planning to become pregnant during the study period - Menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study - Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.) - Received specific treatments/medications /therapy within the designated time period prior to study enrollment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Women's Partners in Health | Austin | Texas |
United States | Women's Health Practice | Champaign | Illinois |
United States | Downtown Women's Healthcare | Denver | Colorado |
United States | Grand Rapids Women's Health | Grand Rapids | Michigan |
United States | ActivMed Practices & Research | Haverhill | Massachusetts |
United States | TMC Life Research | Houston | Texas |
United States | Jackson Clinic | Jackson | Tennessee |
United States | NEA Women's Clinic | Jonesboro | Arkansas |
United States | Adams Patterson OBGYN | Memphis | Tennessee |
United States | Miami Research Associates | Miami | Florida |
United States | Tidewater Physicians for Women | Norfolk | Virginia |
United States | Segal Institiute for Clinical Research | North Miami | Florida |
United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
United States | Precision Trials | Phoenix | Arizona |
United States | Women's Health Research | Phoenix | Arizona |
United States | Women's Health Research Center | Plainsboro | New Jersey |
United States | All Women's Healthcare of West Broward | Plantation | Florida |
United States | Atlanta North Gynecology | Roswell | Georgia |
United States | Saginaw Valley Medical Research Group | Saginaw | Michigan |
United States | Women's Health Center Inc | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Graceway Pharmaceuticals, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | proportion of subjects with therapeutic cure | day 21 to day 30 | No |
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