Postmenopausal Pessary Users: Estrogen Versus Trimosan

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Estradiol; Estrogens; Estrogens, Conjugated (USP)

Criteria

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