Trial | NCT00803335  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    conjugated equine estrogens ...

  • Study Participants

    54
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.
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
Study Started
Dec 31
2008
Primary Completion
May 31
2011
Study Completion
May 31
2011
Last Update
May 27
2015
Estimate

Drug Vaginal conjugated estrogen cream 0.5gm

Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

  • Other names: Premarin

Drug Vaginal conjugated estrogen cream 1.0gm

Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

  • Other names: Premarin

Premarin cream 0.5gm Active Comparator

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

Premarin cream 1.0gm Active Comparator

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

No intervention No Intervention

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

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)
No Results Posted