Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00803335
Eligibility 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT00803335
Study Brief:
Protocol Section:
NCT00803335