Vaginal Estradiol Use in Pessary Care

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary outcome of this study compare the rate of pessary discontinuation at 6 months post-pessary fitting in women using vaginal estradiol versus those not using vaginal estradiol.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of South Florida
• Treatments: Estradiol

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Postmenopausal status

• Recent pessary fitting

• Office-based and home-based pessary care

Exclusion Criteria:

• Women < 18 years old

• Women currently on hormone replacement therapy (pill, patch, pellet)

• Women currently using vaginal estradiol cream within the last 4 weeks

• Medical contraindications to vaginal estradiol including unevaluated vaginal bleeding

• Inability to apply vaginal estradiol cream

• Inability to provide informed consent

• Inability to comprehend written and/or spoken English or Spanish

• Inability to comply with study visit schedule