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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Vehicle Controlled Study Evaluating the Therapeutic Equivalence and Safety of GDC-229 (Investigational Metronidazole 0.75% Vaginal Gel) and Metronidazole 0.75% Vaginal Gel in the Treatment of Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: GDC-229
* Drug: Metronidazole Vaginal Gel 0.75%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Drug<br>GDC-229 gel applied vaginally as directed. | Drug: GDC-229<br>* GDC-229 is a vaginal gel.<br>|
| Active Comparator: Reference Drug<br>Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. | Drug: Metronidazole Vaginal Gel 0.75%<br>* Metronidazole Vaginal Gel 0.75% is an FDA-approved drug<br>|
| Placebo Comparator: Vehicle Placebo Gel<br>GDC-229 Vehicle | Drug: Placebo<br>* Inactive arm of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | Resolution of clinical signs and symptoms | Day 21-30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BV, bacterial vaginosis, vaginal infection