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Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

NCT01886794 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-10-29

Study results available
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Summary

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

Conditions

  • Pelvic Floor Disorders

Interventions

DRUG

Postmenopausal, topical vaginal estrogen cream

Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.

DRUG

Placebo Comparator: Postmenopausal, topical placebo cream

Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Kathleen Vincent, MD · UTMB Galveston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-06
Primary Completion
2023-12-11
Completion
2023-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01886794 on ClinicalTrials.gov