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Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse

NCT01648751 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-09-19

Study results available
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Summary

This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.

Conditions

  • Pelvic Organ Prolapse

Interventions

DRUG

Vaginal estrogen

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

DRUG

Placebo

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Sponsors & Collaborators

  • American Urogynecologic Society

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Pfizer

    collaborator INDUSTRY

  • Pamela Moalli

    lead OTHER

Principal Investigators

  • Laura C Skoczylas, MD, MS · University of Pittsburgh

  • Pamela Moalli, MD, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2023-03-02
Completion
2023-03-02

Countries

  • United States

Study Locations

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Drugs
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 NCT01648751 on ClinicalTrials.gov