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Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

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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

Tracking Information
First Submitted Date  ICMJE October 15, 2007
First Posted Date  ICMJE October 17, 2007
Results First Submitted Date  ICMJE December 2, 2009
Results First Posted Date  ICMJE January 7, 2010
Last Update Posted Date January 12, 2010
Study Start Date  ICMJE September 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2007)
Recurrent Bacterial Vaginosis [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
Recurrence of BV. [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT00545181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Official Title  ICMJE Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE
  • Drug: Vaginal acidifying gel (RepHresh)
    placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.
    Other Name: RepHresh vaginal gel.
  • Drug: Metronidazole control
    oral metronidazole therapy alone
    Other Name: metronidazole
Study Arms  ICMJE
  • Experimental: Metronidazole plus gel
    Receive metronidazole plus vaginal gel
    Intervention: Drug: Vaginal acidifying gel (RepHresh)
  • Active Comparator: Control- metronidazole alone
    Oral Metronidazole antibiotic therapy alone
    Intervention: Drug: Metronidazole control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2009)
55
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00545181
Other Study ID Numbers  ICMJE 0612-58 (Study #)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David M. Haas, Indiana University School of Medicine
Study Sponsor  ICMJE Indiana University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Haas, MD Indiana University School of Medicine
PRS Account Indiana University
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP