drugset / Trial / NCT07030426

Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

NCT07030426

Phase 3 Not yet recruiting 180 enrolled Queen's University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-01
Primary completion
2027-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator conjugated estrogens Other / unclassified 0.5 g Other

Indications