NCT00803335

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

The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.

Conditions

• Pelvic Organ Prolapse
• Vaginal Atrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-12-05
• Last updated: 2015-05-27

Locations

1 site across 1 country: United States