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

Arm | Intervention/treatment |
---|---|
Experimental: Metronidazole plus gel
Receive metronidazole plus vaginal gel
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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 |
- 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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes 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

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
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | David M Haas, MD | Indiana University School of Medicine |
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 |
bacterial vaginosis vaginal acidifying gel recurrence |
Vaginosis, Bacterial Vaginal Diseases Bacterial Infections Bacterial Infections and Mycoses Infections Vaginitis |
Metronidazole Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents |