Prevention of Persistence of Bacterial Vaginosis - Full Text View

Sponsor:	Embil Pharmaceutical Co. Ltd
Information provided by:	Embil Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:	NCT00741845

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 III

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:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

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 ]

Estimated Enrollment:	255
Study Start Date:	June 2008
Estimated 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:	Lale Kavak, MD, Embil Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00741845 History of Changes
Other Study ID Numbers:	Embil-2008Peru
Study First Received:	August 25, 2008
Last Updated:	January 8, 2010
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 February 09, 2012