Clinical trial NCT01055106: Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Official title: A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaginosis, Bacterial
Vaginal Infection
Keywords: bacterial vaginosis
vaginal infection
vaginal discharge
vaginal disease
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of subjects with therapeutic cure
timeFrame: day 21 to day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Jonesboro
country: United States
facility: NEA Women's Clinic
state: Arkansas
city: San Diego
country: United States
facility: Women's Health Center Inc
state: California
city: Denver
country: United States
facility: Downtown Women's Healthcare
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: North Miami
country: United States
facility: Segal Institiute for Clinical Research
state: Florida
city: Plantation
country: United States
facility: All Women's Healthcare of West Broward
state: Florida
city: Roswell
country: United States
facility: Atlanta North Gynecology
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Haverhill
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Grand Rapids
country: United States
facility: Grand Rapids Women's Health
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group
state: Michigan
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Memphis
country: United States
facility: Adams Patterson OBGYN
state: Tennessee
city: Austin
country: United States
facility: Women's Partners in Health
state: Texas
city: Houston
country: United States
facility: TMC Life Research
state: Texas
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
Study officials:
affiliation: Graceway Pharmaceuticals
name: Sharon F Levy, MD
role: STUDY_DIRECTOR
References:
citation: Chavoustie SE, Jacobs M, Reisman HA, Waldbaum AS, Levy SF, Hillier SL, Nyirjesy P. Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study. J Low Genit Tract Dis. 2015 Apr;19(2):129-34. doi: 10.1097/LGT.0000000000000062.