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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Graceway Pharmaceuticals, LLC
• Treatments: Metronidazole

Criteria

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