Phase 3
Completed N=871
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
Source: ClinicalTrials.gov NCT03091777 ↗Enrolled (actual)
871
Serious AEs
0.5%
Results posted
Oct 2019
Primary outcomePrimary: Clinical Cure — 135; 129; 74 Participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure |
135; 129; 74 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Non-pregnant female aged ≥ 18 years who is in good general health
- Diagnosis of BV
- Willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial
- Subjects of childbearing potential who have a negative urine pregnancy test at the Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout the study
- Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol
Exclusion Criteria
- History of alcohol or substance abuse
- Experienced a clinically significant medical event within 90 days
- Abnormal pap or high risk human papillomavirus (HPV)
- 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
- Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
- Primary or secondary immunodeficiency
- Evidence of any vulvovaginitis at screening other than BV
- 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
- Participating in another clinical trial
Data sourced from ClinicalTrials.gov (NCT03091777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.