Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen (NCT02431897) | Clinical Trial Compass
CompletedPhase 4
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
United States206 participantsStarted 2016-12
Plain-language summary
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.
Who can participate
Age range
48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal: no menses for \>1 year
* Minimum age: 48 years
* Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
* No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
* Medically fit for elective surgery
* Physically able to apply/insert the study drug
* Available for clinic follow-up for minimum 1yr
Exclusion Criteria:
* Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
* BMI \>35 kg/m2
* Recent history (within last month) of vaginal infection or vaginitis
* Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
* History of connective tissue disease
* Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
* History of vaginal irradiation
* Allergy to Premarin or its constituents
* Prior apical repair or use of mesh for prolapse repair
* Current tobacco use
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
Timeframe: 12 months
Trial details
NCT IDNCT02431897
SponsorUniversity of Texas Southwestern Medical Center