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

Menopause Clinical Trial

— EPPA  

Official title:

Estrogen Therapy as Prevention in the Progression of Aneurysm

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01895881
• Other study ID #: EPPA - 12101906
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: December 2018

Study information

• Verified date: December 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 52 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm
• Menopause
• Treatment

Intervention

Drug:
• Estradiol

• Placebo

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in levels of serum markers from baseline and six months.
Secondary	Radiographic change in the cerebral vasculature after treatment.		From date of randomization to six months.