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Clinical trialNCT02431897CompletedPhase 4Interventional

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

SponsorUniversity of Texas Southwestern Medical CenterEnrollment206CystocelePelvic Floor DisordersPelvic Organ ProlapseUrogenital ProlapseUterine ProlapseVaginal Prolapse+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Conjugated Estrogens CreamPlacebo Cream
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2016
Primary completion
29 Nov 2021
Completion
17 May 2023
Last update posted
6 Sept 2023
Registered enrollment
206
Registry id
NCT02431897

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.