The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
Information source: TriHealth Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pelvic Organ Prolapse; Vaginal Atrophy
Intervention: conjugated equine estrogen cream (Premarin Vaginal Cream) (Drug); conjugated equine estrogen cream (Premarin Vaginal Cream) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: TriHealth Inc. Overall contact:
Christine M Vaccaro, D.O., Phone: 513-862-4171, Email: Christine_Vaccaro@trihealth.com
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.
Clinical Details
Official title: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
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)
Locations and Contacts
Christine M Vaccaro, D.O., Phone: 513-862-4171, Email: Christine_Vaccaro@trihealth.com
Trihealth (Good Samaritan Hospital, Bethesda North Hospital), Cincinnati, Ohio 45220, United States; Recruiting
Christine M Vaccaro, D.O., Phone: 513-862-4171, Email: Christine_Vaccaro@trihealth.com
Rachel Pauls, M.D., Phone: 513-862-4171, Email: Rachel_Pauls@trihealth.com
Christine M Vaccaro, D.O., Principal Investigator
Rachel Pauls, M.D., Sub-Investigator
George Mutema, M.D., Sub-Investigator
Additional Information
Starting date: December 2008
Ending date: June 2011
Last updated: May 19, 2009
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