TerminatedPhase 4

Postmenopausal Pessary Users: Estrogen Versus Trimosan

Stopped: Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel

United States4 participantsStarted 2019-05-07

Plain-language summary

The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.

Who can participate

Age range40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy * Is a new pessary user, or has not had a pessary for a year Exclusion Criteria: * Pregnancy * Persistent Bacterial Vaginosis infection in the first two clinic encounters * Currently on hormone replacement therapy * Previously on hormone replacement therapy in the past 6 months * Currently on antibiotics * Patients with existing vaginal erosions/ulcerations

What they're measuring

Vaginal pH as Measured by pH Strips

Timeframe: baseline

Vaginal pH as Measured by pH Strips

Timeframe: 3 months

Trial details

NCT IDNCT03943823

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-08

Results submitted2023-02-06

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