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

Sponsor

TriHealth Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT00803335

Collaborator

(none)

Enrollment

Location

Arms

28.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Vaginal Atrophy	Drug: Vaginal conjugated estrogen cream 0.5gm Drug: Vaginal conjugated estrogen cream 1.0gm	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

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. [baseline and 2-12 weeks after treatment (at time of surgery)]

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. [baseline and 2-12 weeks after treatment (at time of surgery)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts 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)