Status:
TERMINATED
Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Pfizer
Conditions:
Microscopic Hematuria
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The hypothesis is that postmenopa...
Detailed Description
This is a randomized controlled trial of vaginal estrogen cream for postmenopausal women with microscopic hematuria (AMH). Potential subjects will be screened with a dipstick urinalysis of a catheteri...
Eligibility Criteria
Inclusion
- Post-menopausal women
- Asymptomatic microscopic hematuria (three or more red blood cells per high powered field on a single urine microscopy) in the absence of urinary tract infection.
Exclusion
- Known urologic disease
- Presence of gross hematuria
- Presence of indwelling urologic foreign body (foley catheter, ureteral stent)
- Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast allergy)
- History of pelvic irradiation or malignancy
- Not a candidate for vaginal estrogen
- Allergy to vaginal estrogen
- Current or prior diagnosis of breast or endometrial cancer
- History of deep vein thrombosis/pulmonary embolus
- Hypercoagulable state
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02213757
Start Date
August 1 2014
End Date
December 1 2015
Last Update
March 15 2023
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20001