Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Summary
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.
Description
This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.
Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.
Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.
Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Conditions
Vaginosis, Bacterial
Intervention
GW05, GW05, GW05, Metronidazole
Location
Precision Trials
Phoenix
Arizona
United States
85032
Status
Completed
Source
Graceway Pharmaceuticals, LLC
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01055106
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:11:01-0400
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PubMed Articles
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Medical and Biotech [MESH] Definitions
Gardnerella
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).
Gardnerella Vaginalis
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.
Mobiluncus
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.
Lactobacillus Crispatus
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.
Vaginosis, Bacterial
Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli.
