Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

A Multi-Center, Double-Blind, Parallel Group Study Comparing the Bioequivalence of Teva Pharmaceuticals, USA's Generic Formulation of Metronidazole Vaginal Gel, 0.75% and MetroGel-Vaginal® Metronidazole Vaginal Gel, 0.75% in the Treatment of Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020396
• Other study ID #: TCR-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 24, 2009
• Last updated: November 24, 2009
• Start date: January 2002
• Est. completion date: March 2003

Study information

• Verified date: November 2009
• Source: Teva Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must provide written informed consent prior to any study related procedures being performed.

• Female subjects must have a clinical diagnosis of bacterial vaginosis, defined as having the presence of "clue cells" > 20% of the total epithelia cells on microscopic examination of a saline "wet mount" and all of the following criteria: Off-white (milky or grey), thin, homogeneous discharge; pH of vaginal fluid > 4.7; a positive 10% KOH "whiff test".

• Subjects must be 18 years of age or older with no known medical conditions that, in the investigator's opinion, may interfere with study participation.

• Women of child bearing potential must have a negative urine pregnancy test result upon entry into the study.

• Subjects must agree to abstain from sexual intercourse throughout the first 7 days of the study. Following the first 7 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.

• Subjects must be willing to abstain from alcohol ingestion during the 5 day treatment period and for 1 day afterward.

• Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).

Exclusion Criteria:

• Subjects with known or suspected other infectious causes of vulvovaginitis (e.g. candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator's opinion, would confound the interpretation of the clinical response).

• Subjects with a Gram's stain slide Nugent score <4.

• Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization.

• Subjects who have taken disulfuram within 14 days or randomization.

• Subjects who have demonstrated a previous hypersensitivity reaction to metronidazole, either orally or topically administered, or any form or parabens.

• Subjects with primary or secondary immunodeficiency.

• Women who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.

• Subjects who are pregnant, breast feeding, or planning a pregnancy.

• Subjects who are menstruating at the time of diagnosis.

• Subjects with intrauterine devices.

• Concurrent anticoagulation therapy with coumadin or warfarin.

• Concurrent use of systemic corticosteroids or systemic antibiotics.

• Subjects with clinically significant unstable medical disorders, life threatening diseases or current malignancies.

• Subjects previously enrolled in this study.

• Subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days.

• Subjects who are unwilling or unable to comply with the requirements of the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole
Vaginal Gel, 0.75%
• Metronidazole
Vaginal Gel, 0.75%

Locations

Country	Name	City	State
United States	Anderson Family Care	Anderson	South Carolina
United States	Carolina OB/GYN	Anderson	South Carolina
United States	Primary Care Associates	Anderson	South Carolina
United States	Radiant Research	Anderson	South Carolina
United States	Millennium Clinical Research Center, LLC	Arlington	Virginia
United States	Kings County Hospital Center	Brooklyn	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Women's Health Practice	Champaign	Illinois
United States	Chapel Hill Obstetrics and Gynecology, PA	Chapel Hill	North Carolina
United States	Cooperfield Obstetrics and Gynecology, LLC	Concord	North Carolina
United States	Meadowcrest Women's Center	Crystal River	Florida
United States	Office of H. Sharon Sethi	Fairfax	Virginia
United States	Women's Health Associates, PC	Fairfax	Virginia
United States	Edinger Medical Group	Fountain Valley	California
United States	Florida Medical and Research Institute, PA	Gainesville	Florida
United States	Clinic for Women, PA	Huntsville	Alabama
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	The Florida Wellcare Alliance, LC	Inverness	Florida
United States	Wellness Center for Gyn & Osteoporosis	Inverness	Florida
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Medford Women's Clinic	Medford	Oregon
United States	Research Memphis	Memphis	Tennessee
United States	Phoenix Ob-Gyn Associated	Moorestown	New Jersey
United States	Phoenix Ob-Gyn Associates	Mount Holly	New Jersey
United States	New Orleans Institute of Clinical Investigation	New Orleans	Louisiana
United States	Florida Medical and Research Institute, PA	Ocala	Florida
United States	O.U. Physicians' Building	Oklahoma City	Oklahoma
United States	The OU Medical Center	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Services Center	Oklahoma City	Oklahoma
United States	Philadelphia Women's Research	Philadelphia	Pennsylvania
United States	MedSource, Inc.	Richmond	Virginia
United States	Office of Max S. Maizels, MD	Richmond	Virginia
United States	Office of Prescott W. Prillaman, MD, PC	Richmond	Virginia
United States	KGR, LLC	Riverdale	Georgia
United States	Elite Medical Research, Inc.	Sellersville	Pennsylvania
United States	Stonebridge OB/GYN Associates	Sellersville	Pennsylvania
United States	Office of Drs. Shepard and Lugerner, PC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic cure rate of the subject at the Test-of-Cure Visit.		Visit 3	No
Primary	Incidence of Adverse Effects reported throughout the study.		29 Days	Yes
Secondary	Therapeutic cure rate at the Post-Treatment Visit		Visit 2	No