Status:
WITHDRAWN
Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
Lead Sponsor:
Rush University Medical Center
Conditions:
Cerebral Aneurysm
Menopause
Eligibility:
FEMALE
40-52 years
Phase:
PHASE2
Brief Summary
This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.
Detailed Description
This is a prospective, randomized, placebo-control trial to test the effect of estradiol in the prevention of progression of cerebral aneurysms. To evaluate the effect, each subject will be treated wi...
Eligibility Criteria
Inclusion
- Generally healthy women, 40-52 years of age.
- At least one documented saccular intracranial cerebral aneurysm detected via catheter angiography, magnetic resonance angiography or computed tomography angiography.
- Clinical diagnosis of perimenopause, defined as regular or irregular menses with or without vasomotor symptoms.
Exclusion
- Known or suspected estrogen-dependent neoplasia.
- Endometrial proliferation, hyperplasia, or malignancy at screening.
- Known hypersensitivity to estrogens, progestins.
- History of myocardial infarction, ischemic heart disease, lipid disorder, or congestive heart failure.
- Known or suspected pregnancy, or recent breast feeding (within 6 months).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01895881
Start Date
April 1 2013
End Date
December 1 2018
Last Update
January 5 2021
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612