Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
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Purpose
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 | Intervention |
|---|---|
|
Bacterial Vaginosis |
Drug: Vaginal acidifying gel (RepHresh) Drug: Metronidazole control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Recurrent Bacterial Vaginosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 55 |
| Study Start Date: | September 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | David M Haas, MD | Indiana University School of Medicine |
More Information
No publications provided
| Responsible Party: | David M. Haas, Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00545181 History of Changes |
| Other Study ID Numbers: | 0612-58 (Study #) |
| Study First Received: | October 15, 2007 |
| Results First Received: | December 2, 2009 |
| Last Updated: | January 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
bacterial vaginosis vaginal acidifying gel recurrence |
Additional relevant MeSH terms:
|
Vaginal Diseases Genital Diseases, Female Vaginosis, Bacterial Bacterial Infections Vaginitis Metronidazole Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 23, 2013