Prevention of Persistence of Bacterial Vaginosis

This study has been terminated.

(Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.)

Sponsor:

Information provided by (Responsible Party):

Embil Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT00741845

First received: August 25, 2008

Last updated: March 5, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 25, 2008
Last Updated Date	March 5, 2012
Start Date ^ICMJE	June 2008
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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00741845 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Arm (s)	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
Enrollment ^ICMJE	117
Completion Date	Not Provided
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
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Peru

Administrative Information
NCT Number ^ICMJE	NCT00741845
Other Study ID Numbers ^ICMJE	Embil-2008Peru
Has Data Monitoring Committee	Not Provided
Responsible Party	Embil Pharmaceutical Co. Ltd
Study Sponsor ^ICMJE	Embil Pharmaceutical Co. Ltd
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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