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

Primary Purpose

Pelvic Organ Prolapse, Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vaginal conjugated estrogen cream 0.5gm
Vaginal conjugated estrogen cream 1.0gm
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, vaginal atrophy, atrophic vaginitis, postmenopausal, posthysterectomy, vaginal health, vaginal cytology, vaginal maturity index, vaginal histology, quality of life questionnaires

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Premarin cream 0.5gm

Premarin cream 1.0gm

No intervention

Arm Description

Application of 0.5gm of vaginal estrogen cream nightly until surgery.

Application of 1.0gm of vaginal estrogen cream nightly until surgery.

Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.

Outcomes

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.

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.

Full Information

First Posted
December 4, 2008
Last Updated
May 25, 2015
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00803335
Brief Title
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
Official Title
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Vaginal Atrophy
Keywords
pelvic organ prolapse, vaginal atrophy, atrophic vaginitis, postmenopausal, posthysterectomy, vaginal health, vaginal cytology, vaginal maturity index, vaginal histology, quality of life questionnaires

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premarin cream 0.5gm
Arm Type
Active Comparator
Arm Description
Application of 0.5gm of vaginal estrogen cream nightly until surgery.
Arm Title
Premarin cream 1.0gm
Arm Type
Active Comparator
Arm Description
Application of 1.0gm of vaginal estrogen cream nightly until surgery.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.
Intervention Type
Drug
Intervention Name(s)
Vaginal conjugated estrogen cream 0.5gm
Other Intervention Name(s)
Premarin
Intervention Description
Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
Intervention Type
Drug
Intervention Name(s)
Vaginal conjugated estrogen cream 1.0gm
Other Intervention Name(s)
Premarin
Intervention Description
Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Vaccaro, DO
Organizational Affiliation
Good Samaritan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

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

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