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Prevention of Persistence 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.
 
ClinicalTrials.gov Identifier: NCT00741845
Recruitment Status : Terminated (Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.)
First Posted : August 26, 2008
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):
Embil Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE August 25, 2008
First Posted Date  ICMJE August 26, 2008
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2008)		 The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights [ Time Frame: 28 days after therapy initiation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Persistence of Bacterial Vaginosis
Official Title  ICMJE Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole
Brief Summary This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE Drug: intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
Study Arms  ICMJE
  • Active Comparator: 1
    intravaginal metronidazole 750mg + 200mg miconazole
    Intervention: Drug: intravaginal metronidazole
  • Active Comparator: 2
    intravaginal metronidazole 750mg
    Intervention: Drug: intravaginal metronidazole
  • Active Comparator: 3
    intravaginal metronidazole 37.5mg
    Intervention: Drug: intravaginal 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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 5, 2012)		 117
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2008)		 255
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women 18-40 yrs old
  • abnormal vaginal discharge or malodor
  • positive QuickVue test
  • positive KOH whiff test
  • Positive finding of clue cells greater than or equal to 20% on wet mount
  • Able to give informed consent
  • willing to abstain from alcohol during the 5 day therapy and 1 day following

Exclusion Criteria:

  • immunocompromised women
  • symptomatic VVC
  • pregnancy or positive pregnancy test
  • menstruating or breastfeeding women
  • other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
  • women with MPC, PID
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00741845
Other Study ID Numbers  ICMJE Embil-2008Peru
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Embil Pharmaceutical Co. Ltd
Original Responsible Party Lale Kavak, MD, Embil Pharmaceutical Company
Current Study Sponsor  ICMJE Embil Pharmaceutical Co. Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Embil Pharmaceutical Co. Ltd
Verification Date March 2012

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