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Trial record 12 of 55 for:    "Vaginitis" | "Metronidazole"

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

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ClinicalTrials.gov Identifier: NCT01020396
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE November 24, 2009
First Posted Date  ICMJE November 25, 2009
Last Update Posted Date November 25, 2009
Study Start Date  ICMJE January 2002
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
  • Therapeutic cure rate of the subject at the Test-of-Cure Visit. [ Time Frame: Visit 3 ]
  • Incidence of Adverse Effects reported throughout the study. [ Time Frame: 29 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
Therapeutic cure rate at the Post-Treatment Visit [ Time Frame: Visit 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE
  • Drug: Metronidazole
    Vaginal Gel, 0.75%
  • Drug: Metronidazole
    Vaginal Gel, 0.75%
    Other Name: MetroGel-Vaginal®
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2009)
579
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01020396
Other Study ID Numbers  ICMJE TCR-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Teva Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceuticals USA
Verification Date November 2009

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