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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00465894
Eligibility Criteria:
Inclusion Criteria:
* Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia
* Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period
* Women age 40-90
* Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)\>40 to ensure post-menopausal status
* Community dwelling
* Ambulatory
* Ability to participate in a 12 month study
Exclusion Criteria:
* Post-void residual volume\>150ml
* Glaucoma without ophthalmologist clearance
* Hormone replacement therapy in the past 6 months
* Current anticholinergic treatment
* Breast cancer
* Impaired mental status
* Undiagnosed vaginal bleeding in the past 12 months
* Endometrial thickness on pelvic ultrasound \>5mm
* History of thromboembolic event
* Gynecologic cancer
* Untreated urinary tract infection (would be eligible after treatment)
* Stage III pelvic organ prolapse or greater
* Recent diuretic medication changes (one month from change)
* Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida)
* Congestive heart failure
* Prior pelvic irradiation
* Interstitial cystitis
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT00465894
Study Brief:
Protocol Section:
NCT00465894