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

Phase 2

Withdrawn

• Conditions: Cerebral Aneurysm; Menopause; Treatment
• Interventions: Drug: Placebo; Drug: Estradiol

• Registration Number: NCT01895881
• Lead Sponsor: Rush University Medical Center

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-07-07
• Study First Posted: 2013-07-11
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for 180 days.
Estradiol Daily	Estradiol	1 mg Estradiol daily for 180 days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Radiographic change in the cerebral vasculature after treatment.	From date of randomization to six months.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States