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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803335
• Other study ID #: 08135-08-076
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2008
• Last updated: May 25, 2015
• Start date: December 2008
• Est. completion date: May 2011

Study information

• Verified date: February 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Atrophy

Intervention

Drug:
• Vaginal conjugated estrogen cream 0.5gm
Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
• Vaginal conjugated estrogen cream 1.0gm
Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

Locations

Country	Name	City	State
United States	Trihealth (Good Samaritan Hospital, Bethesda North Hospital)	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline and 2-12 weeks after treatment (at time of surgery)	No
Secondary	Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.		baseline and 2-12 weeks after treatment (at time of surgery)	No