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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01895881
Recruitment Status : Withdrawn (Unable to Recruit Participants)
First Posted : July 11, 2013
Last Update Posted : January 5, 2021
Information provided by (Responsible Party):
Michael Chen, M.D., Rush University Medical Center

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

Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Menopause Treatment Drug: Estradiol Drug: Placebo Phase 2

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 with either oral estradiol or placebo for 6 months. Subjects will be randomly assigned to 1 of 2 groups as follows:

Double Blind Treatment Group Open-Label Regimen A1 1 mg Estradiol daily for 180 days B1 Placebo for 180 days

Each group will be given oral Progesterone (3300 mg) for 10 days at the end of 90 days regardless of menstrual pattern. Subjects will be asked to keep a menstrual calendar throughout the trial. Serum markers will be drawn at baseline and every 90 days with the results blinded until the end of the trial. Magnetic resonance angiography (MRA) studies of the brain will be performed at month 6.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Estrogen Therapy as Prevention in the Progression of Aneurysm
Study Start Date : April 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Estradiol Daily
1 mg Estradiol daily for 180 days.
Drug: Estradiol
Placebo Comparator: Placebo
Placebo for 180 days.
Drug: Placebo

Primary Outcome Measures :
  1. Effect of low dose estradiol on a panel of serum markers. [ Time Frame: Change in levels of serum markers from baseline and six months. ]
    Parallel design double-blind placebo controlled trial to assess the effect of low dose estradiol on serum lipoprotein (a), serum elastase, and homocysteine.

Secondary Outcome Measures :
  1. Radiographic change in the cerebral vasculature after treatment. [ Time Frame: From date of randomization to six months. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01895881

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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Principal Investigator: Michael Chen, MD Rush University Medical Center
Principal Investigator: Barbara Soltes, MD Rush University Medical Center
Publications of Results:
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Responsible Party: Michael Chen, M.D., Associate Professor of Neurology, Neurosurgery and Radiology, Rush University Medical Center Identifier: NCT01895881    
Other Study ID Numbers: EPPA - 12101906
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michael Chen, M.D., Rush University Medical Center:
Intracranial Aneurysm
Additional relevant MeSH terms:
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Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs