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NOT YET RECRUITING
NCT07030426
PHASE3

Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

Sponsor: Queen's University

View on ClinicalTrials.gov

Summary

This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.

Official title: A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-10-01

Completion Date

2029-09-30

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

DRUG

Vaginal Estrogen - Twice Weekly

Twice weekly for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime .

DRUG

Vaginal Estrogen - Daily

Daily for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime.

Locations (2)

Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada