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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
  Purpose

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 Intervention Phase
Bacterial Vaginosis
 Drug: intravaginal metronidazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Embil Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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 ]

Enrollment: 117
Study Start Date: June 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741845

Locations
Peru
Cayetano Heredia Hospital
Lima, Urb Ingenieria, Peru
Sponsors and Collaborators
Embil Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Embil Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00741845     History of Changes
Other Study ID Numbers: Embil-2008Peru
Study First Received: August 25, 2008
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Radiation-Sensitizing Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 18, 2013