Expired Study
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Cincinnati, Ohio 45220


Purpose:

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.


Study summary:

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


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)


NCT ID:

NCT00803335


Primary Contact:

Principal Investigator
Christine M Vaccaro, DO
Good Samaritan Hospital


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45220
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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