Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

Completed · Phase 2

Conditions studied: Vaginosis, Bacterial, Vaginal Infection

In brief

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.

Key facts

Study ID

NCT01055106

Run by

Graceway Pharmaceuticals, LLC

People needed

255

Starts

2010-01-01

Expected to finish

2010-04-01

Last updated by the study team

2011-07-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Women's Health Research — Phoenix, Arizona, United States
• Precision Trials — Phoenix, Arizona, United States
• NEA Women's Clinic — Jonesboro, Arkansas, United States
• Women's Health Center Inc — San Diego, California, United States
• Downtown Women's Healthcare — Denver, Colorado, United States
• Miami Research Associates — Miami, Florida, United States
• Segal Institiute for Clinical Research — North Miami, Florida, United States
• All Women's Healthcare of West Broward — Plantation, Florida, United States
• Atlanta North Gynecology — Roswell, Georgia, United States
• Women's Health Practice — Champaign, Illinois, United States
• ActivMed Practices & Research — Haverhill, Massachusetts, United States
• Grand Rapids Women's Health — Grand Rapids, Michigan, United States
• Saginaw Valley Medical Research Group — Saginaw, Michigan, United States
• Women's Health Research Center — Plainsboro, New Jersey, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Jackson Clinic — Jackson, Tennessee, United States
• Adams Patterson OBGYN — Memphis, Tennessee, United States
• Women's Partners in Health — Austin, Texas, United States
• TMC Life Research — Houston, Texas, United States
• Tidewater Physicians for Women — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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