NCT01055106

Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Graceway Pharmaceuticals, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vaginosis, Bacterial
• Vaginal Infection

Interventions

Type	Name	Description
DRUG	GW05	vaginal gel once daily regimen A
DRUG	GW05	vaginal gel once daily regimen B
DRUG	GW05	vaginal gel once daily regimen C
DRUG	Metronidazole	vaginal gel 0.75% once daily for 5 days

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-01-25
• Last updated: 2011-07-01

Locations

20 sites across 1 country: United States