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

November 24, 2009
November 24, 2009
January 2002
March 2003   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Therapeutic cure rate at the Post-Treatment Visit [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Bacterial Vaginosis
  • Drug: Metronidazole
    Vaginal Gel, 0.75%
  • Drug: Metronidazole
    Vaginal Gel, 0.75%
    Other Name: MetroGel-Vaginal®
  • Experimental: 1
    Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)
    Intervention: Drug: Metronidazole
  • Active Comparator: 2
    MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)
    Intervention: Drug: Metronidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
579
March 2003
March 2003   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01020396
TCR-03
Not Provided
Not Provided
Teva Pharmaceuticals USA
Not Provided
Not Provided
Teva Pharmaceuticals USA
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP