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NCT02431897 · ClinicalTrials.gov registry record · Phase 4
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 206
- Enrollment target
NCT02431897 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 206 participants.
The verdict
NCT02431897, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 206 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo Cream
- DRUG Conjugated Estrogens Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2016-12 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02431897
The ClinicalTrials.gov registry entry for NCT02431897 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Cream is the first listed.
NCT02431897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02431897 about?
NCT02431897 is a clinical study titled "Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen". 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 ...
What is the current status of trial NCT02431897?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 206 participants. The study started on 2016-12. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT02431897?
The interventions under investigation include: Placebo Cream (DRUG), Conjugated Estrogens Cream (DRUG).
Who is sponsoring clinical trial NCT02431897?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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