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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
proportion of subjects with therapeutic cure	day 21 to day 30

Secondary Outcome Measures

Name	Time	Method

Locations (20): Women's Health Research
🇺🇸
Phoenix, Arizona, United States
NEA Women's Clinic
🇺🇸
Jonesboro, Arkansas, United States
Miami Research Associates
🇺🇸
Miami, Florida, United States
Precision Trials
🇺🇸
Phoenix, Arizona, United States
Downtown Women's Healthcare
🇺🇸
Denver, Colorado, United States
Women's Health Center Inc
🇺🇸
San Diego, California, United States
All Women's Healthcare of West Broward
🇺🇸
Plantation, Florida, United States
Atlanta North Gynecology
🇺🇸
Roswell, Georgia, United States
Segal Institiute for Clinical Research
🇺🇸
North Miami, Florida, United States
Saginaw Valley Medical Research Group
🇺🇸
Saginaw, Michigan, United States
Women's Health Practice
🇺🇸
Champaign, Illinois, United States
Grand Rapids Women's Health
🇺🇸
Grand Rapids, Michigan, United States
ActivMed Practices & Research
🇺🇸
Haverhill, Massachusetts, United States
Jackson Clinic
🇺🇸
Jackson, Tennessee, United States
Drexel University College of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Women's Health Research Center
🇺🇸
Plainsboro, New Jersey, United States
Adams Patterson OBGYN
🇺🇸
Memphis, Tennessee, United States
TMC Life Research
🇺🇸
Houston, Texas, United States
Tidewater Physicians for Women
🇺🇸
Norfolk, Virginia, United States
Women's Partners in Health
🇺🇸
Austin, Texas, United States