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

TriHealth

Status and phase: Completed; Phase 3

Conditions: Vaginal Atrophy; Pelvic Organ Prolapse

Treatments: Drug: Vaginal conjugated estrogen cream 1.0gm; Drug: Vaginal conjugated estrogen cream 0.5gm

Study type: Interventional

Funder types: Other

Identifiers

NCT00803335

08135-08-076

Details and patient eligibility

About

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.

Full description

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

Enrollment: 54 patients

Sex: Female

Ages: 45+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Premarin cream 0.5gm

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal conjugated estrogen cream 0.5gm

Premarin cream 1.0gm

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal conjugated estrogen cream 1.0gm

No intervention

No Intervention group

Description:

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