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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

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)