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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03097120
The ClinicalTrials.gov registry entry for NCT03097120 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,036-participant average among 31 other Heart Disease trials with a reported enrollment target (85% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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