Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

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 postmenopausal women with blood in the urine (microscopic hematuria) will have higher rates of resolution of hematuria after treatment course with vaginal conjugated equine estrogen cream compared to placebo cream

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborator: Pfizer
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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