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The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse

NCT00803335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-05-27

No results posted yet for this study

Summary

The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Conditions

  • Pelvic Organ Prolapse
  • Vaginal Atrophy

Interventions

DRUG

Vaginal conjugated estrogen cream 0.5gm

Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

DRUG

Vaginal conjugated estrogen cream 1.0gm

Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Christine M Vaccaro, DO · Good Samaritan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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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 NCT00803335 on ClinicalTrials.gov