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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01055106
Other study ID # GW05-0904
Secondary ID
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


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
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