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NCT01778985 · ClinicalTrials.gov registry record · Phase 4
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01778985 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT01778985, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. The investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. The results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.
Interventions
- OTHER Placebo
- DRUG Premarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01778985
The ClinicalTrials.gov registry entry for NCT01778985 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 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 is the first listed.
NCT01778985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01778985 about?
NCT01778985 is a clinical study titled "Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor". This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal c...
What is the current status of trial NCT01778985?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2012-12. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01778985?
The interventions under investigation include: Placebo (OTHER), Premarin (DRUG).
Who is sponsoring clinical trial NCT01778985?
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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