Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
(TBVAP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKate V Meriwether, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of New Mexico

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kate V Meriwether, MD

Principal Investigator

University of New Mexico

Eligibility Criteria

Inclusion Criteria

Female

Indications for initiation of pessary use and planning to be fitted for and wear a pessary

Treatment Details

Interventions

Trimo-San gel (Antimicrobial Agent)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Trimo-San groupExperimental Treatment1 Intervention

Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly

Group II: Control groupActive Control1 Intervention

Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel