Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
This study is currently recruiting participants.
Verified by Indiana University, July 2008
Sponsored by: Indiana University School of Medicine
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00545181
  Purpose

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.


Condition Intervention
Bacterial Vaginosis
Drug: Vaginal acidifying gel (RepHresh)

Drug Information available for: Metronidazole Metronidazole hydrochloride Metronidazole phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title: Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-Blinded Controlled Trial

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Recurrent bacterial vaginosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Receive metronidazole plus vaginal gel
Drug: Vaginal acidifying gel (RepHresh)
placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545181

Contacts
Contact: David M Haas, MD 3176307837 dahaas@iupui.edu

Locations
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: David M Haas, MD            
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: David M Haas, MD Indiana University School of Medicine
  More Information

Responsible Party: Indiana University School of Medicine ( David M. Haas )
Study ID Numbers: Study 0612-58
Study First Received: October 15, 2007
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00545181  
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
bacterial vaginosis
vaginal acidifying gel
recurrence

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Metronidazole
Vaginosis, Bacterial
Vaginitis
Vaginal Diseases
Recurrence

ClinicalTrials.gov processed this record on January 14, 2009