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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03033160
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal, defined by amenorrhea for at least one year or a bilateral oophorectomy at least one year prior, and have three or more red blood cells per high powered field visible in a properly collected urine specimen without evidence of infection. In addition, women must have a negative cystoscopy and computed tomography urogram (or magnetic resonance urography if history of renal insufficiency or contrast allergy) within the past three years.
Exclusion Criteria:
* Current or past thromboembolic disorder or cerebrovascular accident
* Intolerance to previous estrogen replacement therapy or hormone replacement therapy
* Estrogen dependent neoplasm within the past five years (unless supporting documentation from patient's oncologist is obtained)
* Estrogen replacement therapy or hormone replacement therapy within the past three months or selective estrogen receptor modulators within eight weeks of enrollment
* Urinary tract infection
* Urinary calculi
* Urinary tract malignancy
* Vaginal bleeding of unknown origin
* Urethral caruncle
* History of recurrent urinary tract infections in the last one year
* Stage two or greater pelvic organ prolapse.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03033160
Study Brief:
Protocol Section:
NCT03033160