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NCT05317364 · ClinicalTrials.gov registry record · Phase 4
Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT05317364 is a Phase 4 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 38 participants.
The verdict
NCT05317364, a Phase 4 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality. Currently, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact. The primary outcome of this study will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's score and the fecal incontinence quality of life (FIQOL) questionnaire for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS.
Interventions
- DRUG Estradiol 0.01% Vag Cream
- DRUG Placebo vaginal cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2026-02-13 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05317364
The ClinicalTrials.gov registry entry for NCT05317364 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Estradiol 0.01% Vag Cream is the first listed.
NCT05317364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05317364 about?
NCT05317364 is a clinical study titled "Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery". Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency resu...
What is the current status of trial NCT05317364?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2022-07-14. Estimated completion is 2026-02-13.
What interventions are being tested in trial NCT05317364?
The interventions under investigation include: Estradiol 0.01% Vag Cream (DRUG), Placebo vaginal cream (DRUG).
Who is sponsoring clinical trial NCT05317364?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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