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

Vaginal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055106
• Other study ID #: GW05-0904
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2010
• Last updated: June 28, 2011
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: Graceway Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vaginal Diseases
• Vaginal Infection
• Vaginosis, Bacterial

Intervention

Drug:
• GW05
vaginal gel once daily regimen A
• GW05
vaginal gel once daily regimen B
• GW05
vaginal gel once daily regimen C
• Metronidazole
vaginal gel 0.75% once daily for 5 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of subjects with therapeutic cure		day 21 to day 30	No