Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis - Full Text View

Purpose

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	Intervention	Phase
Vaginosis, Bacterial Vaginal Infection	Drug: GW05 Drug: Metronidazole	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

Drug Information available for: Metronidazole Metronidazole hydrochloride

U.S. FDA Resources

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

proportion of subjects with therapeutic cure [ Time Frame: day 21 to day 30 ] [ Designated as safety issue: No ]


Enrollment:	255
Study Start Date:	January 2010
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055106

Locations


United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
Women's Health Research
Phoenix, Arizona, United States, 85015
United States, Arkansas
NEA Women's Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Women's Health Center Inc
San Diego, California, United States, 92123
United States, Colorado
Downtown Women's Healthcare
Denver, Colorado, United States, 80218
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
Segal Institiute for Clinical Research
North Miami, Florida, United States, 33161
All Women's Healthcare of West Broward
Plantation, Florida, United States, 33324
United States, Georgia
Atlanta North Gynecology
Roswell, Georgia, United States, 30075
United States, Illinois
Women's Health Practice
Champaign, Illinois, United States, 61820
United States, Massachusetts
ActivMed Practices & Research
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Grand Rapids Women's Health
Grand Rapids, Michigan, United States, 49503
Saginaw Valley Medical Research Group
Saginaw, Michigan, United States, 48604
United States, New Jersey
Women's Health Research Center
Plainsboro, New Jersey, United States, 08536
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, Tennessee
Jackson Clinic
Jackson, Tennessee, United States, 38305
Adams Patterson OBGYN
Memphis, Tennessee, United States, 38120
United States, Texas
Women's Partners in Health
Austin, Texas, United States, 78705
TMC Life Research
Houston, Texas, United States, 77054
United States, Virginia
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

Investigators


Study Director:	Sharon F Levy, MD	Graceway Pharmaceuticals

More Information

No publications provided


Responsible Party:	Sharon F. Levy, MD / Vice President Product Develpoment, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01055106 History of Changes
Other Study ID Numbers:	GW05-0904
Study First Received:	January 21, 2010
Last Updated:	June 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:


bacterial vaginosis vaginal infection vaginal discharge vaginal disease

Additional relevant MeSH terms:


Infection Vaginosis, Bacterial Bacterial Infections Genital Diseases, Female Vaginal Diseases Vaginitis Metronidazole	Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015