Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).