Clinical trial NCT01020396: Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bacterial Vaginosis
Keywords: Bioequivalence
Metronidazole
Vaginosis
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 579
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic cure rate of the subject at the Test-of-Cure Visit.
timeFrame: Visit 3
measure: Incidence of Adverse Effects reported throughout the study.
timeFrame: 29 Days
Secondary outcomes:
measure: Therapeutic cure rate at the Post-Treatment Visit
timeFrame: Visit 2
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinic for Women, PA
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Fountain Valley
country: United States
facility: Edinger Medical Group
state: California
city: Washington
country: United States
facility: Office of Drs. Shepard and Lugerner, PC
state: District of Columbia
city: Crystal River
country: United States
facility: Meadowcrest Women's Center
state: Florida
city: Gainesville
country: United States
facility: Florida Medical and Research Institute, PA
state: Florida
city: Inverness
country: United States
facility: The Florida Wellcare Alliance, LC
state: Florida
city: Inverness
country: United States
facility: Wellness Center for Gyn & Osteoporosis
state: Florida
city: Ocala
country: United States
facility: Florida Medical and Research Institute, PA
state: Florida
city: Riverdale
country: United States
facility: KGR, LLC
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: New Orleans
country: United States
facility: New Orleans Institute of Clinical Investigation
state: Louisiana
city: Moorestown
country: United States
facility: Phoenix Ob-Gyn Associated
state: New Jersey
city: Mount Holly
country: United States
facility: Phoenix Ob-Gyn Associates
state: New Jersey
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Chapel Hill Obstetrics and Gynecology, PA
state: North Carolina
city: Concord
country: United States
facility: Cooperfield Obstetrics and Gynecology, LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: O.U. Physicians' Building
state: Oklahoma
city: Oklahoma City
country: United States
facility: The OU Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Services Center
state: Oklahoma
city: Medford
country: United States
facility: Medford Women's Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Women's Research
state: Pennsylvania
city: Sellersville
country: United States
facility: Elite Medical Research, Inc.
state: Pennsylvania
city: Sellersville
country: United States
facility: Stonebridge OB/GYN Associates
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Family Care
state: South Carolina
city: Anderson
country: United States
facility: Carolina OB/GYN
state: South Carolina
city: Anderson
country: United States
facility: Primary Care Associates
state: South Carolina
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Memphis
country: United States
facility: Research Memphis
state: Tennessee
city: Arlington
country: United States
facility: Millennium Clinical Research Center, LLC
state: Virginia
city: Fairfax
country: United States
facility: Women's Health Associates, PC
state: Virginia
city: Fairfax
country: United States
facility: Office of H. Sharon Sethi
state: Virginia
city: Richmond
country: United States
facility: MedSource, Inc.
state: Virginia
city: Richmond
country: United States
facility: Office of Max S. Maizels, MD
state: Virginia
city: Richmond
country: United States
facility: Office of Prescott W. Prillaman, MD, PC
state: Virginia
Study officials:
References: