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

Primary Purpose

Cerebral Aneurysm, Menopause, Treatment

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Estradiol
Placebo
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Aneurysm focused on measuring Intracranial Aneurysm, Estradiol

Eligibility Criteria

40 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Estradiol Daily

Placebo

Arm Description

1 mg Estradiol daily for 180 days.

Placebo for 180 days.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
May 24, 2013
Last Updated
December 30, 2020
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01895881
Brief Title
Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
Acronym
EPPA
Official Title
Estrogen Therapy as Prevention in the Progression of Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to Recruit Participants
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm, Menopause, Treatment
Keywords
Intracranial Aneurysm, Estradiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estradiol Daily
Arm Type
Experimental
Arm Description
1 mg Estradiol daily for 180 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 180 days.
Intervention Type
Drug
Intervention Name(s)
Estradiol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect of low dose estradiol on a panel of serum markers.
Description
Parallel design double-blind placebo controlled trial to assess the effect of low dose estradiol on serum lipoprotein (a), serum elastase, and homocysteine.
Time Frame
Change in levels of serum markers from baseline and six months.
Secondary Outcome Measure Information:
Title
Radiographic change in the cerebral vasculature after treatment.
Time Frame
From date of randomization to six months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chen, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Soltes, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21990811
Citation
Chen M, Ouyang B, Goldstein-Smith L, Feldman L. Oral contraceptive and hormone replacement therapy in women with cerebral aneurysms. J Neurointerv Surg. 2011 Jun;3(2):163-6. doi: 10.1136/jnis.2010.003855. Epub 2010 Dec 17.
Results Reference
result
PubMed Identifier
22700728
Citation
Ding C, Toll V, Ouyang B, Chen M. Younger age of menopause in women with cerebral aneurysms. J Neurointerv Surg. 2013 Jul;5(4):327-31. doi: 10.1136/neurintsurg-2012-010364. Epub 2012 Jun 13.
Results Reference
result

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

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