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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: intravaginal metronidazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole
Study Start Date : June 2008
Actual Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
intravaginal metronidazole 750mg + 200mg miconazole
 Drug: intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
Active Comparator: 2
intravaginal metronidazole 750mg
 Drug: intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
Active Comparator: 3
intravaginal metronidazole 37.5mg
 Drug: intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741845


Locations
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Peru
Cayetano Heredia Hospital
Lima, Urb Ingenieria, Peru
Sponsors and Collaborators
Embil Pharmaceutical Co. Ltd
More Information
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Responsible Party: Embil Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00741845    
Other Study ID Numbers: Embil-2008Peru
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents