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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01020396
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Bacterial Vaginosis
Drug: Metronidazole
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Therapeutic cure rate of the subject at the Test-of-Cure Visit. [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
  • Incidence of Adverse Effects reported throughout the study. [ Time Frame: 29 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Therapeutic cure rate at the Post-Treatment Visit [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]

Enrollment: 579
Study Start Date: January 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020396

  Show 37 Study Locations
Sponsors and Collaborators
Teva Pharmaceuticals USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01020396     History of Changes
Other Study ID Numbers: TCR-03
Study First Received: November 24, 2009
Last Updated: November 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Metronidazole
Vaginosis

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 16, 2014