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

Information source: Graceway Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vaginosis, Bacterial; Vaginal Infection

Intervention: GW05 (Drug); GW05 (Drug); GW05 (Drug); Metronidazole (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Graceway Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Sharon F Levy, MD, Study Director, Affiliation: Graceway Pharmaceuticals

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.

Clinical Details

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

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

Primary outcome: proportion of subjects with therapeutic cure

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Precision Trials, Phoenix, Arizona 85032, United States

Women's Health Research, Phoenix, Arizona 85015, United States

NEA Women's Clinic, Jonesboro, Arkansas 72401, United States

Women's Health Center Inc, San Diego, California 92123, United States

Downtown Women's Healthcare, Denver, Colorado 80218, United States

Miami Research Associates, Miami, Florida 33143, United States

Segal Institiute for Clinical Research, North Miami, Florida 33161, United States

All Women's Healthcare of West Broward, Plantation, Florida 33324, United States

Atlanta North Gynecology, Roswell, Georgia 30075, United States

Women's Health Practice, Champaign, Illinois 61820, United States

ActivMed Practices & Research, Haverhill, Massachusetts 01830, United States

Grand Rapids Women's Health, Grand Rapids, Michigan 49503, United States

Saginaw Valley Medical Research Group, Saginaw, Michigan 48604, United States

Women's Health Research Center, Plainsboro, New Jersey 08536, United States

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States

Jackson Clinic, Jackson, Tennessee 38305, United States

Adams Patterson OBGYN, Memphis, Tennessee 38120, United States

Women's Partners in Health, Austin, Texas 78705, United States

TMC Life Research, Houston, Texas 77054, United States

Tidewater Physicians for Women, Norfolk, Virginia 23502, United States

Additional Information

Starting date: January 2010
Last updated: June 28, 2011

Page last updated: August 23, 2015

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