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

Sponsor

Rush University Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01895881

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Estradiol Daily

1 mg Estradiol daily for 180 days.

Drug: Estradiol

Placebo Comparator: Placebo

Placebo for 180 days.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Radiographic change in the cerebral vasculature after treatment. [From date of randomization to six months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 52 Years

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

Principal Investigator: Michael Chen, MD, Rush University Medical Center
Principal Investigator: Barbara Soltes, MD, Rush University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Chen, M.D., Associate Professor of Neurology, Neurosurgery and Radiology, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT01895881

Other Study ID Numbers:

EPPA - 12101906

First Posted:

Jul 11, 2013

Last Update Posted:

Jan 5, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Michael Chen, M.D., Associate Professor of Neurology, Neurosurgery and Radiology, Rush University Medical Center

Intracranial Aneurysm

Estradiol

Additional relevant MeSH terms:

Intracranial Aneurysm

Aneurysm

Estradiol

Study Results

No Results Posted as of Jan 5, 2021