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NCT01471457 · ClinicalTrials.gov registry record · Phase 2
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
A Phase 2 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
NCT01471457 is a Phase 2 study that has completed, run by University of New Mexico. The registered enrollment target is 184 participants.
The verdict
NCT01471457, a Phase 2 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 184 participants
- Enrollment target
Study Summary
The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for \>1 year are recruited in to the study and randomized to using Trimo-San gel daily or not using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain, but will have a positive effect on the subjective symptoms experienced by women wearing pessaries.
Interventions
- DRUG Trimo-San gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01471457
The ClinicalTrials.gov registry entry for NCT01471457 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of New Mexico, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trimo-San gel is the first listed.
NCT01471457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01471457 about?
NCT01471457 is a clinical study titled "Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis". The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for \>1 year are recruited in to the st...
What is the current status of trial NCT01471457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2009-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01471457?
The interventions under investigation include: Trimo-San gel (DRUG).
Who is sponsoring clinical trial NCT01471457?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
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