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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Rush University Medical Center
Sponsor:
Collaborator:
The Brain Aneurysm Foundation
Information provided by (Responsible Party):
Michael Chen, M.D., Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01895881
First received: May 24, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Cerebral Aneurysm
Perimenopause
Drug: Estradiol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Estrogen Therapy as Prevention in the Progression of Aneurysm

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Effect of low dose estradiol on a panel of serum markers. [ Time Frame: Change in levels of serum markers from baseline and six months. ] [ Designated as safety issue: Yes ]
    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:
  • Radiographic change in the cerebral vasculature after treatment. [ Time Frame: From date of randomization to six months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: April 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol Daily
1 mg Estradiol daily for 180 days.
Drug: Estradiol
Placebo Comparator: Placebo
Placebo for 180 days.
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895881

Contacts
Contact: Christy Anton 312-942-1489 Christy_Anton@rush.edu
Contact: Valerie Toll, ACNP 312-563-2817 Valerie_Toll@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Michael Chen, MD         
Principal Investigator: Barbara Soltes, MD         
Sponsors and Collaborators
Rush University Medical Center
The Brain Aneurysm Foundation
Investigators
Principal Investigator: Michael Chen, MD Rush University Medical Center
Principal Investigator: Barbara Soltes, MD Rush University Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Michael Chen, M.D., Associate Professor of Neurology, Neurosurgery and Radiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01895881     History of Changes
Other Study ID Numbers: EPPA - 12101906
Study First Received: May 24, 2013
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Intracranial Aneurysm
Estradiol

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 28, 2014