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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Genital Diseases, Female
Vaginal Diseases
Vaginitis
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014