Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Estrogen Therapy as Prevention in the Progression of Aneurysm|
- Effect of low dose estradiol on a panel of serum markers. [ Time Frame: Change in levels of serum markers from baseline and six months. ] [ Designated as safety issue: Yes ]Parallel design double-blind placebo controlled trial to assess the effect of low dose estradiol on serum lipoprotein (a), serum elastase, and homocysteine.
- Radiographic change in the cerebral vasculature after treatment. [ Time Frame: From date of randomization to six months. ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Estradiol Daily
1 mg Estradiol daily for 180 days.
Placebo Comparator: Placebo
Placebo for 180 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01895881
|Contact: Christy Anton||312-942-1489||Christy_Anton@rush.edu|
|Contact: Danielle Zielinski, ACNP||312-563-4411||Danielle_Zielinski@rush.edu|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Principal Investigator: Michael Chen, MD|
|Principal Investigator: Barbara Soltes, MD|
|Principal Investigator:||Michael Chen, MD||Rush University Medical Center|
|Principal Investigator:||Barbara Soltes, MD||Rush University Medical Center|