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

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.

This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.

Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.

Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.

Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection.

• Vaginosis, Bacterial
• Vaginal Infection

• Drug: GW05
  vaginal gel once daily regimen A
• Drug: GW05
  vaginal gel once daily regimen B
• Drug: GW05
  vaginal gel once daily regimen C
• Drug: Metronidazole
  vaginal gel 0.75% once daily for 5 days

• Active Comparator: 1D
  Intervention: Drug: GW05
• Active Comparator: 3D
  Intervention: Drug: GW05
• Active Comparator: 5D
  Intervention: Drug: GW05
• Active Comparator: Metronidazole
  Intervention: Drug: Metronidazole

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