Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis (TBVAP)
This study is currently recruiting participants.
Verified February 2013 by University of New Mexico
Sponsor:
University of New Mexico
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01471457
First received: November 10, 2011
Last updated: March 4, 2013
Last verified: February 2013
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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 |
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
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471457
Contacts
| Contact: Kate V Meriwether, MD | 5052495967 | meriwet2@salud.unm.edu |
| Contact: Rebecca G Rogers, MD | 5052729712 | RRogers@salud.unm.edu |
Locations
| United States, District of Columbia | |
| Washington Hospital Center | Completed |
| Washington, District of Columbia, United States, 20010 | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kate V Meriwether, MD 505-249-5967 meriwet2@salud.unm.edu | |
| Contact: Lisa Power 5052729898 LPower@salud.unm.edu | |
| Sub-Investigator: Rebecca G Rogers, MD | |
| Principal Investigator: Kate V Meriwether, MD | |
Sponsors and Collaborators
University of New Mexico
Investigators
| Principal Investigator: | Kate V Meriwether, MD | University of New Mexico |
More Information
Additional Information:
Publications:
| 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: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of New Mexico:
|
bacterial vaginosis pessary discharge |
Additional relevant MeSH terms:
|
Vaginosis, Bacterial Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013