Who is sponsoring NCT03097120?

NCT03097120 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT03097120?

Interventions in NCT03097120: 0.625 mg of conjugated equine estrogen, 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate, placebo tablets.

What condition does NCT03097120 study?

NCT03097120 studies Heart Disease.

Is NCT03097120 still recruiting?

NCT03097120 is currently completed. Last updated 19 May 2023.

Last reviewed 2023-05-19 · How we verify

NCT03097120: ERA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Estrogen Replacement and Atherosclerosis Trial

Completed Phase 3 Last updated 19 May 2023

What this trial tests

Phase 3 trial testing 0.625 mg of conjugated equine estrogen in Heart Disease in 309 participants. Completed in 1 January 2001.

Timeline

1 January 1995

Primary endpoint
1 January 2001

1 January 2001

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	309
Start date	1 January 1995
Primary completion	1 January 2001
Estimated completion	1 January 2001
Sites	1 location across United States

Drugs / interventions tested

0.625 mg of conjugated equine estrogen — full drug profile →
0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate — full drug profile →
placebo tablets — full drug profile →

Conditions studied

Heart Disease — all drugs for Heart Disease →

Sponsor

Wake Forest University Health Sciences

Who can join

55 and older, female only, with Heart Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

mean minimal coronary-artery diameter
Time frame: at average of 3.2 years follow-up
mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03097120 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 19 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03097120.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing