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N/A N=54 Randomized Single-blind Treatment

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Bacterial Vaginosis

Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Recurrent Bacterial Vaginosis — 7; 7 Participants — p=0.75

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Vaginal acidifying gel (RepHresh) (Drug); Metronidazole control (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Indiana University
Primary completion
Jul 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Recurrent Bacterial Vaginosis
7; 7 0.75

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.

Eligibility Criteria

Inclusion Criteria

  • All women of between 18-50 years of age.
  • Confirmed current diagnosis of BV using Amsel's criteria.
  • 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

  • Patient who received antibiotic therapy within the past two weeks.
  • Patients who had co-existing gonorrhea or Chlamydia infection
  • Any contraindications or sensitivity to taking the vaginal gel.
  • Allergy to metronidazole
  • Alcoholics or those unable to abstain from alcohol consumption.
  • Pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00545181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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