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

NCT01895881 | Withdrawn Phase 2

• 1 other identifier: EPPA - 12101906
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Aneurysm; Menopause; Treatment

Keywords

Intracranial Aneurysm; Estradiol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic change in the cerebral vasculature after treatment.

  From date of randomization to six months.

Study Arms (2)

Estradiol Daily

EXPERIMENTAL

1 mg Estradiol daily for 180 days.

Drug: Estradiol

Placebo

PLACEBO COMPARATOR

Placebo for 180 days.

Drug: Placebo

Interventions

Estradiol DRUG

Estradiol Daily

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related 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.

  PMID: 21990811 RESULT

• 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.

  PMID: 22700728 RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Michael Chen, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Barbara Soltes, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, Neurosurgery and Radiology

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 11, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

US (1)