Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

NCT00545181 | Completed Results DMC

• 1 other identifier: 0612-58 (Study #)
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosis; vaginal acidifying gel; recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrent Bacterial Vaginosis

  Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH \>4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.

  3 months

Study Arms (2)

Metronidazole plus gel

EXPERIMENTAL

Receive metronidazole plus vaginal gel

Drug: Vaginal acidifying gel (RepHresh)

Control- metronidazole alone

ACTIVE COMPARATOR

Oral Metronidazole antibiotic therapy alone

Drug: Metronidazole control

Interventions

Vaginal acidifying gel (RepHresh) DRUG

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

Also known as: RepHresh vaginal gel.

Metronidazole plus gel

Metronidazole control DRUG

oral metronidazole therapy alone

Also known as: metronidazole

Control- metronidazole alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Recurrence

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: David Haas, MD MS
• Organization: Indiana University School of Medicine

dahaas@iupui.edu

3176307837

Study Officials

• David M Haas, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 12, 2010
• Results First Posted: January 7, 2010

Record last verified: 2010-01

Locations

US (1)