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Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

NCT02431897 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2023-09-06

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse
  • Urogenital Prolapse
  • Vaginal Vault Prolapse
  • Cystocele
  • Uterine Prolapse
  • Vaginal Prolapse
  • Pelvic Floor Disorders

Interventions

DRUG

Conjugated Estrogens Cream

0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for \>5 weeks before surgery, then 2x/week for 1 year after surgery.

DRUG

Placebo Cream

1g applied vaginally nightly for 2 weeks then 2x/week for \>5 weeks before surgery, then 2x/week for 1 year after surgery.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • David D Rahn, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-11-29
Completion
2023-05-17

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431897 on ClinicalTrials.gov