Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
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|ClinicalTrials.gov Identifier: NCT03091777|
Recruitment Status : Completed
First Posted : March 27, 2017
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Drug: GDC-229 Drug: Metronidazole Vaginal Gel 0.75% Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||871 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||March 10, 2017|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||March 27, 2018|
Experimental: Test Drug
GDC-229 gel applied vaginally as directed.
GDC-229 is a vaginal gel.
Active Comparator: Reference Drug
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Drug: Metronidazole Vaginal Gel 0.75%
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
Placebo Comparator: Vehicle Placebo Gel
Inactive arm of the study
- Clinical Cure [ Time Frame: Day 21-30 ]Resolution of clinical signs and symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091777
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27612|