Recruiting
Phase 3

Vaginal Estrogen

Sponsor:

Sarah Wozney

Code:

NCT07030426

Conditions

Pelvic Organ Prolapse (POP)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vaginal Estrogen - Twice Weekly

Vaginal Estrogen - Daily

Study Details

Brief 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)

Study ID

NCT07030426

Start date

Jan 1, 2026

Status verified date

Aug, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:

1. Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
2. The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.
3. Age ≥18 years at the time of consent.
4. Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.
5. Primary or recurrent prolapse surgery without a history of mesh surgery.
6. Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.
7. Plans to reside in the study area for at least 2 years after their surgery.

Exclusion Criteria

Any individual meeting any of the following criteria is not eligible for participation in this study:

1. Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
2. Participant undergoing obliterative procedures.
3. Participant with a history of mesh surgery for prolapse.
4. Participant undergoing uterine sparing surgery.
5. Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:

  • Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container.
  • Liver dysfunction or disease as long as liver function tests have failed to return to normal.
  • Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer).
  • Endometrial hyperplasia.
  • Known, suspected, or past history of breast cancer.
  • Undiagnosed abnormal genital bleeding.
  • Known or suspected pregnancy
  • Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease).
  • Partial or complete loss of vision due to ophthalmic vascular disease.
  • Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies).
6. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.
7. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No Vaginal Estrogen Group

No vaginal estrogen

active comparator: Twice Weekly Vaginal Estrogen Group

Twice Weekly Vaginal Estrogen

active comparator: Daily Vaginal Estrogen Group

Daily Vaginal Estrogen

Interventions

Vaginal Estrogen - Twice Weekly

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

Vaginal Estrogen - Daily

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

Primary outcome measure

  • Recruitment Rate [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L2V7

Contacts

Principal Investigator:

Sarah Wozney, MD, MScHQ

More Information

Sponsor

Sarah Wozney

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • pelvic organ prolapse
  • vaginal estrogen
  • pelvic organ prolapse surgery
  • pelvic organ prolapse repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sarah Wozney on 2026-08-20.