NCT03097120

The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.

The Estrogen Replacement and Atherosclerosis Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects. Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DRUG	0.625 mg of conjugated equine estrogen	one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily
DRUG	0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate	one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily
DRUG	placebo tablets	two placebo tablets daily

Timeline

• Start date: 1995-01-01
• Primary completion: 2001-01-01
• Completion: 2001-01-01
• First posted: 2017-03-31
• Last updated: 2023-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study