The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse - Full Text View

Sponsor:	TriHealth Inc.
Collaborator:	Hatton Institute for Research and Education
Information provided by:	TriHealth Inc.
ClinicalTrials.gov Identifier:	NCT00803335

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.

Condition	Intervention
Pelvic Organ Prolapse Vaginal Atrophy	Drug: conjugated equine estrogen cream (Premarin Vaginal Cream)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:

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. [ Time Frame: baseline and 2-12 weeks after treatment (at time of surgery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology. [ Time Frame: baseline and 2-12 weeks after treatment (at time of surgery) ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator These women will use 0.5 gms of Premarin vaginal cream nightly until scheduled surgery date.	Drug: conjugated equine estrogen cream (Premarin Vaginal Cream) Premarin vaginal cream 0.5 gms, applied to vagina nightly
2: Active Comparator These women will use 1.0 gm of Premarin vaginal cream nightly until scheduled surgery date.	Drug: conjugated equine estrogen cream (Premarin Vaginal Cream) Premarin Vaginal Cream 1.0 gm, applied to vagina nightly
3: No Intervention No cream or other placebo moisturizer will be given.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803335

Contacts

Contact: Christine M Vaccaro, D.O.	513-862-4171	Christine_Vaccaro@trihealth.com
Contact: Angie Fellner, M.A.	513-862-2330	Angie_Fellner@trihealth.com

Locations

United States, Ohio
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)	Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Christine M Vaccaro, D.O. 513-862-4171 Christine_Vaccaro@trihealth.com
Contact: Rachel Pauls, M.D. 513-862-4171 Rachel_Pauls@trihealth.com
Principal Investigator: Christine M Vaccaro, D.O.
Sub-Investigator: Rachel Pauls, M.D.
Sub-Investigator: George Mutema, M.D.

Sponsors and Collaborators

TriHealth Inc.

Hatton Institute for Research and Education

More Information

No publications provided

Responsible Party:	Advanced Urogynecology ( Christine Vaccaro, D.O. )
Study ID Numbers:	08135-08-076
Study First Received:	December 4, 2008
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00803335 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by TriHealth Inc.:

pelvic organ prolapse
vaginal atrophy
atrophic vaginitis
postmenopausal
posthysterectomy

vaginal health
vaginal cytology
vaginal maturity index
vaginal histology
quality of life questionnaires

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Atrophy
Hormones
Prolapse
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010