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

Learn more about:
Related Clinical Trial
Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms Intraoperative Fluorescence With Augmented Reality Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) Amnesia After Surgery for Anterior Communicating Aneurysm: High Resolution Magnetic Resonance (MR) Imaging Findings Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy Esmolol Infusion in Patients Undergoing Craniotomy Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing. Registry for Study of Coils in Intracranial Aneurysms EEG Monitoring to Assess Emergence From Neuroanesthesia DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial Hydrogel Endovascular Aneurysm Treatment Trial Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment Doppler Flow Wires in Cerebral Angiography Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity Use of Classic LMA During Endovascular Therapy HydroCoil Cerebral Aneurysm Treatment Trial Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 Decision Aids in Cerebral Aneurysm Treatment Framing Eighteen Coils in Cerebral Aneurysms Trial Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

Brief Title

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

Official Title

Estrogen Therapy as Prevention in the Progression of Aneurysm

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 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.

Study Phase

Phase 2

Study Type


Primary Outcome

Effect of low dose estradiol on a panel of serum markers.

Secondary Outcome

 Radiographic change in the cerebral vasculature after treatment.


Cerebral Aneurysm



Study Arms / Comparison Groups

 Estradiol Daily
Description:  1 mg Estradiol daily for 180 days.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

April 2013

Completion Date

December 2019

Primary Completion Date

December 2019

Eligibility 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).




40 Years - 52 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Michael Chen, MD, 312-563-2817, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

EPPA - 12101906

Responsible Party

Principal Investigator

Study Sponsor

Rush University Medical Center

Study Sponsor

Michael Chen, MD, Principal Investigator, Rush University Medical Center

Verification Date

January 2018