Estrogen Replacement and Atherosclerosis (ERA) in Older Women

NCT00000549 | Completed Phase 3

• 2 other identifiers: 93U01HL049488
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine if estrogen replacement therapy, with or without low dose progesterone, slows progression or induces regression of coronary atherosclerosis in postmenopausal women.

Conditions

Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause

Interventions

estrogen replacement therapy DRUG

hormone replacement therapy DRUG

estrogens DRUG

progestins DRUG

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Postmenopausal women with established coronary atherosclerosis.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (6)

• Herrington DM, Reboussin DM, Klein KP, Sharp PC, Shumaker SA, Snyder TE, Geisinger KR. The estrogen replacement and atherosclerosis (ERA) study: study design and baseline characteristics of the cohort. Control Clin Trials. 2000 Jun;21(3):257-85. doi: 10.1016/s0197-2456(00)00054-4.

  PMID: 10822123 BACKGROUND

• Folmar S, Oates-Williams F, Sharp P, Reboussin D, Smith J, Cheshire K, Macer J, Potvin Klein K, Herrington D. Recruitment of participants for the Estrogen Replacement and Atherosclerosis (ERA) trial. a comparison of costs, yields, and participant characteristics from community- and hospital-based recruitment strategies. Control Clin Trials. 2001 Feb;22(1):13-25. doi: 10.1016/s0197-2456(00)00117-3.

  PMID: 11165419 BACKGROUND

• Herrington DM, Reboussin DM, Brosnihan KB, Sharp PC, Shumaker SA, Snyder TE, Furberg CD, Kowalchuk GJ, Stuckey TD, Rogers WJ, Givens DH, Waters D. Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. N Engl J Med. 2000 Aug 24;343(8):522-9. doi: 10.1056/NEJM200008243430801.

  PMID: 10954759 BACKGROUND

• Erkkila AT, Lichtenstein AH, Mozaffarian D, Herrington DM. Fish intake is associated with a reduced progression of coronary artery atherosclerosis in postmenopausal women with coronary artery disease. Am J Clin Nutr. 2004 Sep;80(3):626-32. doi: 10.1093/ajcn/80.3.626.

  PMID: 15321802 BACKGROUND

• Herrington DM, Howard TD, Hawkins GA, Reboussin DM, Xu J, Zheng SL, Brosnihan KB, Meyers DA, Bleecker ER. Estrogen-receptor polymorphisms and effects of estrogen replacement on high-density lipoprotein cholesterol in women with coronary disease. N Engl J Med. 2002 Mar 28;346(13):967-74. doi: 10.1056/NEJMoa012952.

  PMID: 11919305 BACKGROUND

• Lakoski SG, Brosnihan B, Herrington DM. Hormone therapy, C-reactive protein, and progression of atherosclerosis: data from the Estrogen Replacement on Progression of Coronary Artery Atherosclerosis (ERA) trial. Am Heart J. 2005 Nov;150(5):907-11. doi: 10.1016/j.ahj.2004.11.025.

  PMID: 16290959 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Heart Diseases; Myocardial Ischemia

Interventions

Estrogen Replacement Therapy; Hormone Replacement Therapy; Estrogens; Progestins

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• David Herrington

  Bowman Gray School of Medicine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: August 1, 1994
• Study Completion: July 1, 2000
• Last Updated: March 16, 2016

Record last verified: 2005-12