Clinical trial NCT01895881: Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
Official title: Estrogen Therapy as Prevention in the Progression of Aneurysm
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cerebral Aneurysm
Menopause
Treatment
Keywords: Intracranial Aneurysm
Estradiol
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Effect of low dose estradiol on a panel of serum markers.
timeFrame: Change in levels of serum markers from baseline and six months.
Secondary outcomes:
measure: Radiographic change in the cerebral vasculature after treatment.
timeFrame: From date of randomization to six months.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Michael Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Barbara Soltes, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.