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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: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT02431897 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 206 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cumulative failures, as measured by (i) anatomic assessment of prolapse, (ii) presence of bulge symptoms, and/or (iii) retreatment of pelvic organ prolapse
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 |
What the finished NCT02431897 record still lists
NCT02431897 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Cream is the first listed.
NCT02431897 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02431897's enrollment target sits among peer trials
206 401st of 2000 higher than 1,599 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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