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NCT00545181 · ClinicalTrials.gov registry record · NA
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT00545181 is a NA study that has completed, run by Indiana University. The registered enrollment target is 55 participants.
The verdict
NCT00545181, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study 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.
Interventions
- DRUG Vaginal acidifying gel (RepHresh)
- DRUG Metronidazole control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00545181
The ClinicalTrials.gov registry entry for NCT00545181 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vaginal acidifying gel (RepHresh) is the first listed.
NCT00545181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00545181 about?
NCT00545181 is a clinical study titled "Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial". 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 inflamma...
What is the current status of trial NCT00545181?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2007-09. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00545181?
The interventions under investigation include: Vaginal acidifying gel (RepHresh) (DRUG), Metronidazole control (DRUG).
Who is sponsoring clinical trial NCT00545181?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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