Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Bacterial Vaginosis Clinical Trial

Official title:

Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545181
• Other study ID #: 0612-58 (Study #)
• Status: Completed
• Phase: N/A
• First received: October 15, 2007
• Last updated: January 6, 2010
• Start date: September 2007
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Vaginal acidifying gel (RepHresh)
placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.
• Metronidazole control
oral metronidazole therapy alone

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Bacterial Vaginosis		3 months	No