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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Vaginal Atrophy
• Intervention / Treatment: Drug: Vaginal conjugated estrogen cream 0.5gm; Drug: Vaginal conjugated estrogen cream 1.0gm

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Premarin cream 0.5gm; Application of 0.5gm of vaginal estrogen cream nightly until surgery.	Drug: Vaginal conjugated estrogen cream 0.5gm; Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.; Other Names: Premarin
Active Comparator: Premarin cream 1.0gm; Application of 1.0gm of vaginal estrogen cream nightly until surgery.	Drug: Vaginal conjugated estrogen cream 1.0gm; Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.; Other Names: Premarin
No Intervention: No intervention; Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 25, 2015
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: postmenopausal; vaginal atrophy; pelvic organ prolapse; atrophic vaginitis; vaginal health; posthysterectomy; vaginal cytology; vaginal maturity index; vaginal histology; quality of life questionnaires
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Atrophy; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estrogens, Conjugated (USP)
• Other Study ID Numbers: 08135-08-076