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Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
This study has been completed.
Study NCT00545181   Information provided by Indiana University
First Received: October 15, 2007   Last Updated: August 7, 2009   History of Changes

October 15, 2007
August 7, 2009
September 2007
July 2009   (final data collection date for primary outcome measure)
Recurrent bacterial vaginosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Recurrence of BV. [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00545181 on ClinicalTrials.gov Archive Site
 
 
 
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Bacterial Vaginosis
Drug: Vaginal acidifying gel (RepHresh)
Experimental: Receive metronidazole plus vaginal gel
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
55
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All women of between 18-50 years of age.
  2. Confirmed current diagnosis of BV using Amsel's criteria.
  3. Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months

Exclusion Criteria:

  1. Patient who received antibiotic therapy within the past two weeks.
  2. Patients who had co-existing gonorrhea or Chlamydia infection
  3. Any contraindications or sensitivity to taking the vaginal gel.
  4. Allergy to metronidazole
  5. Alcoholics or those unable to abstain from alcohol consumption.
  6. Pregnancy
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545181
David M. Haas, Indiana University School of Medicine
0612-58 (Study #)
Indiana University School of Medicine
 
Principal Investigator: David M Haas, MD Indiana University School of Medicine
Indiana University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP