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Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

NCT07030426 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse (POP)

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.

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • Sarah Wozney, MD, MScHQ · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07030426 on ClinicalTrials.gov