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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaginosis, Bacterial, Vaginal Infection

Intervention / Treatment
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* Drug: GW05
* Drug: GW05
* Drug: GW05
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females at least 18 years of age In good general health Confirmed current diagnosis of bacterial vaginosis (determined at study screening) Negative pregnancy test (for women who are able to become pregnant) Must abstain from sexual intercourse throughout the first 7 days of thes study Must abstain from alcohol ingestion during the treatment period and for one day afterward Must not use intra-vaginal products for the duration of the study Exclusion Criteria: Pregnant, lactating, or planning to become pregnant during the study period Menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.) Received specific treatments/medications /therapy within the designated time period prior to study enrollment

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1D<br> | Drug: GW05<br>* vaginal gel once daily regimen A<br>|
| Active Comparator: 3D<br> | Drug: GW05<br>* vaginal gel once daily regimen B<br>|
| Active Comparator: 5D<br> | Drug: GW05<br>* vaginal gel once daily regimen C<br>|
| Active Comparator: Metronidazole<br> | Drug: Metronidazole<br>* vaginal gel 0.75% once daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects with therapeutic cure |  | day 21 to day 30 | 

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