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Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545181
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : January 7, 2010
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Indiana University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Vaginal acidifying gel (RepHresh) Drug: Metronidazole control Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Recurrent Bacterial Vaginosis [ Time Frame: 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545181


Locations
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United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: David M Haas, MD Indiana University School of Medicine
More Information
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Responsible Party: David M. Haas, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00545181    
Other Study ID Numbers: 0612-58 (Study #)
First Posted: October 17, 2007    Key Record Dates
Results First Posted: January 7, 2010
Last Update Posted: January 12, 2010
Last Verified: January 2010
Keywords provided by Indiana University:
bacterial vaginosis
vaginal acidifying gel
recurrence
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis
 Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents