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Hormone Therapy
Kronos Early Estrogen Prevention Study (KEEPS)
Phase 4
Waitlist Available
Led By Howard Hodis, MD
Research Sponsored by Kronos Longevity Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
Summary
The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
Eligible Conditions
- Brachiocephalic Artery Disease
- Menopause
- Hardening of the Arteries
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm 1Active Control4 Interventions
CEE 0.45 mg w/ Prometrium 200 mg patch 0.05 mg w/ Prometrium 200 mg
Group II: Arm 2Placebo Group2 Interventions
Placebo patch, placebo CEE, placebo Prometrium
Find a Location
Who is running the clinical trial?
University of UtahOTHER
1,147 Previous Clinical Trials
1,698,352 Total Patients Enrolled
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,906,841 Total Patients Enrolled
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,222 Total Patients Enrolled
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,768,253 Total Patients Enrolled
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,065,396 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,877,538 Total Patients Enrolled
Yale UniversityOTHER
1,930 Previous Clinical Trials
3,032,746 Total Patients Enrolled
Albert Einstein College of MedicineOTHER
296 Previous Clinical Trials
11,688,725 Total Patients Enrolled
Kronos Longevity Research InstituteLead Sponsor
3 Previous Clinical Trials
609 Total Patients Enrolled
Frederick Naftolin, MD, PhDStudy DirectorKronos Longevity Research Institute