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

2017-03-27 23:08:21 | BioPortfolio

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.

Study Design

Conditions

Bacterial Vaginosis

Intervention

GDC-229, Metronidazole Vaginal Gel 0.75%, Placebo

Location

Site 103
Raleigh
North Carolina
United States
27612

Status

Recruiting

Source

Gage Development Company, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-03-27T23:08:21-0400

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PubMed Articles [4887 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

A genus of bacteria found in the human genital and urinary tract. It is considered to be a major cause of bacterial vaginosis (VAGINOSIS, BACTERIAL).

The only species in the genus GARDNERELLA, and previously classed as Haemophilus vaginalis. This bacterium, also isolated from the female genital tract of healthy women, is implicated in the cause of bacterial vaginosis (VAGINOSIS, BACTERIAL). It occasionally causes postpartum bacteremia and bacteremia following a transurethral resection of the prostate.

A genus of gram-negative, anaerobic, rod-shaped bacteria. Its organisms are found in the human vagina, particularly in association with Gardnerella vaginalis in cases of bacterial vaginosis.

A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and the VAGINA of healthy women. It produces LACTIC ACID and HYDROGEN PEROXIDE, and is used as a PROBIOTIC. It is also used for the treatment and prevention of BACTERIAL VAGINOSIS.

The uptake of substances from the VAGINA via the vaginal epithelium/mucosa.

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