Status:
COMPLETED
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
Lead Sponsor:
TriHealth Inc.
Conditions:
Pelvic Organ Prolapse
Vaginal Atrophy
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
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 appropria...
Detailed Description
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00803335
Start Date
December 1 2008
End Date
May 1 2011
Last Update
May 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
Cincinnati, Ohio, United States, 45220