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

Phase 3

Completed

• Conditions: Pelvic Organ Prolapse; Vaginal Atrophy
• Interventions: Drug: Vaginal conjugated estrogen cream 1.0gm; Drug: Vaginal conjugated estrogen cream 0.5gm

• Registration Number: NCT00803335
• Lead Sponsor: TriHealth Inc.

Brief 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-02
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Women aged 45 years or older
• Postmenopausal (>55 if natural menopause)
• Clinical atrophic vaginitis (at least mild atrophy)
• Pelvic organ prolapse(at least stage 2 or greater)
• Posthysterectomy
• Surgery date between 2-12 weeks after recruitment

Exclusion Criteria

• Uterus present
• Well-estrogenized appearing vagina
• Known or suspected history of breast carcinoma
• Hormone-dependent tumor
• Genital bleeding of unknown cause
• Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
• Vaginal infection requiring treatment
• Allergy to estrogen or its constituents
• Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
• Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
• Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premarin cream 1.0gm	Vaginal conjugated estrogen cream 1.0gm	Application of 1.0gm of vaginal estrogen cream nightly until surgery.
Premarin cream 0.5gm	Vaginal conjugated estrogen cream 0.5gm	Application of 0.5gm of vaginal estrogen cream nightly until surgery.

Primary Outcome Measures

Name	Time	Method
Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.	baseline and 2-12 weeks after treatment (at time of surgery)

Secondary Outcome Measures

Name	Time	Method
Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.	baseline and 2-12 weeks after treatment (at time of surgery)

Trial Locations

Locations (1)

Trihealth (Good Samaritan Hospital, Bethesda North Hospital); 🇺🇸 Cincinnati, Ohio, United States