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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01471457
First received: November 10, 2011
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Bacterial Vaginosis
Drug: Trimo-San gel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Trimo-San Gel for the Prevention of Pessary-associated Bacterial Vaginosis

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Rate of bacterial vaginosis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Vaginal symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Vaginal symptoms and effect of vaginal symptoms on pessary wearers measured before and after pessary fitting by questionnaire based on verified vaginal symptoms questionnaire


Enrollment: 184
Study Start Date: September 2009
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trimo-San group
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
Drug: Trimo-San gel
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
No Intervention: Control group
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

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471457

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Kate V Meriwether, MD University of New Mexico
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01471457     History of Changes
Other Study ID Numbers: 2009-028 
Study First Received: November 10, 2011
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
bacterial
vaginosis
pessary
discharge

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis

ClinicalTrials.gov processed this record on July 24, 2016