drugset / Trial / NCT07030426
Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | conjugated estrogens | Other / unclassified | 0.5 g | Other |