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

This study has been completed.

Sponsor:

Collaborator:

Hatton Institute for Research and Education

Information provided by:

TriHealth Inc.

ClinicalTrials.gov Identifier:

NCT00803335

First received: December 4, 2008

Last updated: July 19, 2011

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2008

Last Updated Date

July 19, 2011

Start Date ^ICMJE

December 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00803335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

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 appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pelvic Organ Prolapse
Vaginal Atrophy

Intervention ^ICMJE

Drug: Vaginal conjugated estrogen cream 0.5gm
Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

Other Name: Premarin
Drug: Vaginal conjugated estrogen cream 1.0gm
Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

Other Name: Premarin

Study Arm (s)

Experimental: Premarin cream 0.5gm
Women in this arm will apply 0.5gm of premarin vaginal cream nightly until surgery.

Intervention: Drug: Vaginal conjugated estrogen cream 0.5gm
Experimental: Premarin cream 1.0gm
Women will apply 1.0gm of premarin vaginal cream nightly until surgery.

Intervention: Drug: Vaginal conjugated estrogen cream 1.0gm
No Intervention: No intervention
Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00803335

Other Study ID Numbers ^ICMJE

08135-08-076

Has Data Monitoring Committee

Responsible Party

Christine Vaccaro, D.O., Advanced Urogynecology

Study Sponsor ^ICMJE

TriHealth Inc.

Collaborators ^ICMJE

Hatton Institute for Research and Education

Investigators ^ICMJE

Principal Investigator:

Christine M Vaccaro, DO

Good Samaritan Hospital

Information Provided By

TriHealth Inc.

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top