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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01020396
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Information provided by:
Teva Pharmaceuticals USA

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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Metronidazole Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 Start Date : January 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: 1
Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)
Drug: Metronidazole
Vaginal Gel, 0.75%

Active Comparator: 2
MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)
Drug: Metronidazole
Vaginal Gel, 0.75%
Other Name: MetroGel-Vaginal®

Primary Outcome Measures :
  1. Therapeutic cure rate of the subject at the Test-of-Cure Visit. [ Time Frame: Visit 3 ]
  2. Incidence of Adverse Effects reported throughout the study. [ Time Frame: 29 Days ]

Secondary Outcome Measures :
  1. Therapeutic cure rate at the Post-Treatment Visit [ Time Frame: Visit 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01020396

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Sponsors and Collaborators
Teva Pharmaceuticals USA

Layout table for additonal information Identifier: NCT01020396     History of Changes
Other Study ID Numbers: TCR-03
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Teva Pharmaceuticals USA:

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents