Status:
COMPLETED
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Lead Sponsor:
University of New Mexico
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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 fitt...
Detailed Description
The study population will consist of women who will be fitted for and initiate use of a pessary for relief of pelvic organ prolapse and/or urinary symptoms. All patients scheduled for pessary fitting...
Eligibility Criteria
Inclusion
- Female
- Indications for initiation of pessary use and planning to be fitted for and wear a pessary
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT01471457
Start Date
September 1 2009
End Date
September 1 2014
Last Update
April 22 2020
Active Locations (2)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
University of New Mexico
Albuquerque, New Mexico, United States, 87131