Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00545181
First received: October 15, 2007
Last updated: January 6, 2010
Last verified: January 2010
  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: Metronidazole control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

Resource links provided by NLM:


Further study details as provided by Indiana University:

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

Enrollment: 55
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole plus gel
Receive metronidazole plus vaginal gel
Drug: Vaginal acidifying gel (RepHresh)
placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.
Other Name: RepHresh vaginal gel.
Active Comparator: Control- metronidazole alone
Oral Metronidazole antibiotic therapy alone
Drug: Metronidazole control
oral metronidazole therapy alone
Other Name: metronidazole

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

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

No publications provided

Responsible Party: David M. Haas, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00545181     History of Changes
Other Study ID Numbers: 0612-58 (Study #)
Study First Received: October 15, 2007
Results First Received: December 2, 2009
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
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 April 15, 2014