Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

NCT ID: NCT00545181

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-07-31

Brief Summary

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.

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.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Metronidazole plus gel

Receive metronidazole plus vaginal gel

Group Type: EXPERIMENTAL

Vaginal acidifying gel (RepHresh)

Intervention Type: DRUG

placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.

Control- metronidazole alone

Oral Metronidazole antibiotic therapy alone

Group Type: ACTIVE_COMPARATOR

Metronidazole control

Intervention Type: DRUG

oral metronidazole therapy alone

Interventions

Vaginal acidifying gel (RepHresh)

placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.

Intervention Type: DRUG

Metronidazole control

oral metronidazole therapy alone

Intervention Type: DRUG

Other Intervention Names

RepHresh vaginal gel.; metronidazole

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Indiana University School of Medicine

Principal Investigators

David M Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0612-58 (Study #)

Identifier Type: -

Identifier Source: org_study_id