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Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

NCT01778985 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-02

Study results available
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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.

Conditions

Interventions

DRUG

Premarin

OTHER

Placebo

Sponsors & Collaborators

  • American Urogynecologic Society Foundation Astellas Research Award

    collaborator UNKNOWN

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01778985 on ClinicalTrials.gov