Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Public ClinicalTrials.gov record NCT01471457. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Use of Trimo-San Gel for the Prevention of Pessary-associated Bacterial Vaginosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01471457
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 184 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Aug 31, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Apr 21, 2020
2009 – 2014
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01471457, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01471457 live on ClinicalTrials.gov.