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NCT03097120 · ClinicalTrials.gov registry record · Phase 3
The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.
A Phase 3 study of Heart Disease, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
- 1
- Study location
NCT03097120: Completed Phase 3 study of Heart Disease, sponsored by Wake Forest University Health Sciences.
NCT03097120 is a Phase 3 study of Heart Disease that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 309 participants, below the 2,036-participant average among 31 other Heart Disease trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03097120, a Phase 3 study of Heart Disease, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis
Conditions Studied
Interventions
- DRUG 0.625 mg of conjugated equine estrogen
- DRUG 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate
- DRUG placebo tablets
Study Locations (1)
North Carolina
- Wake Forest University School of Medicine - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 1995-01 |
| Est. Completion | 2001-01 |
| Phase | Phase 3 |
What the finished NCT03097120 record still lists
NCT03097120 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 2,036-participant average among 31 other Heart Disease trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Heart Disease appearing as the primary indexed condition, and to 3 interventions - of which 0.625 mg of conjugated equine estrogen is the first listed.
NCT03097120 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03097120 about?
NCT03097120 is a clinical study titled "The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.". 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 mod...
What is the current status of trial NCT03097120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 1995-01. Estimated completion is 2001-01.
What conditions does trial NCT03097120 study?
This clinical trial studies the following conditions: Heart Disease.
What interventions are being tested in trial NCT03097120?
The interventions under investigation include: 0.625 mg of conjugated equine estrogen (DRUG), 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (DRUG), placebo tablets (DRUG).
Who is sponsoring clinical trial NCT03097120?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03097120 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03097120's enrollment target sits among peer trials
309 13th of 31 higher than 19 of 31 other Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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