Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis

Exclusion Criteria

• •1. History of alcohol or substance abuse
• •2. Experienced a clinically significant medical event within 90 days
• •3. Abnormal pap or high risk human papillomavirus (HPV)
• •4. History or presence of clinically significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease
• •5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
• •6. Primary or secondary immunodeficiency
• •7. Evidence of any vulvovaginitis at screening other than BV
• •8. History of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle gel
• •9. Participating in another clinical trial