Phase 3
N=184
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT01471457 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Patients With Bacterial Vaginosis at 3 Months — 15; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trimo-San gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Bacterial Vaginosis at 3 Months |
15; 16 | — |
| SECONDARY Participants With Any Bothersome Vaginal Symptom at 3 Months |
30; 24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female
- Indications for initiation of pessary use and planning to be fitted for and wear a pessary
Exclusion Criteria
- Male
- Already using a pessary or have used in the last year
- History of recurrent or chronic bacterial vaginosis with > 2 episodes per year or symptoms reported for > 6 months out of last year
- Active known vaginal infection (symptomatic and/or untreated) or completion of treatment for BV or cervical/vaginal infection within one week of recruitment
- History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment, or HSV with > 2 outbreaks per year or last outbreak < 1 month ago)
- Chronic antibiotic use for indications not listed above
Data sourced from ClinicalTrials.gov (NCT01471457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.