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

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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

Interventional


Primary Outcome

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

Secondary Outcome

 Radiographic change in the cerebral vasculature after treatment.

Condition

Cerebral Aneurysm

Intervention

Estradiol

Study Arms / Comparison Groups

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

Publications

* 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

Drug

Estimated Enrollment

26

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).
      

Gender

Female

Ages

40 Years - 52 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01895881

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