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

Sponsor

Graceway Pharmaceuticals, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01055106

Collaborator

(none)

255

Enrollment

Locations

Arms

Duration (Months)

12.8

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginosis, Bacterial Vaginal Infection	Drug: GW05 Drug: GW05 Drug: GW05 Drug: Metronidazole	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

255 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1D	Drug: GW05 vaginal gel once daily regimen A
Active Comparator: 3D	Drug: GW05 vaginal gel once daily regimen B
Active Comparator: 5D	Drug: GW05 vaginal gel once daily regimen C
Active Comparator: Metronidazole	Drug: Metronidazole vaginal gel 0.75% once daily for 5 days

Outcome Measures

Primary Outcome Measures

proportion of subjects with therapeutic cure [day 21 to day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Health Research	Phoenix	Arizona	United States	85015
2	Precision Trials	Phoenix	Arizona	United States	85032
3	NEA Women's Clinic	Jonesboro	Arkansas	United States	72401
4	Women's Health Center Inc	San Diego	California	United States	92123
5	Downtown Women's Healthcare	Denver	Colorado	United States	80218
6	Miami Research Associates	Miami	Florida	United States	33143
7	Segal Institiute for Clinical Research	North Miami	Florida	United States	33161
8	All Women's Healthcare of West Broward	Plantation	Florida	United States	33324
9	Atlanta North Gynecology	Roswell	Georgia	United States	30075
10	Women's Health Practice	Champaign	Illinois	United States	61820
11	ActivMed Practices & Research	Haverhill	Massachusetts	United States	01830
12	Grand Rapids Women's Health	Grand Rapids	Michigan	United States	49503
13	Saginaw Valley Medical Research Group	Saginaw	Michigan	United States	48604
14	Women's Health Research Center	Plainsboro	New Jersey	United States	08536
15	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
16	Jackson Clinic	Jackson	Tennessee	United States	38305
17	Adams Patterson OBGYN	Memphis	Tennessee	United States	38120
18	Women's Partners in Health	Austin	Texas	United States	78705
19	TMC Life Research	Houston	Texas	United States	77054
20	Tidewater Physicians for Women	Norfolk	Virginia	United States	23502