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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: Completed Phase 2 study, sponsored by University of New Mexico.
NCT01471457 is a Phase 2 study that has completed, run by University of New Mexico. The registered enrollment target is 184 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group
Interventions
- DRUG Trimo-San gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01471457 record still lists
NCT01471457 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 1 intervention - of which Trimo-San gel is the first listed.
NCT01471457 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01471457's enrollment target sits among peer trials
184 360th of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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