Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154180
Status:
UNKNOWN
Last Update Posted:
2009-09-14
First Post:
2005-09-07
Brief Title:
Kronos Early Estrogen Prevention Study KEEPS
Sponsor:
Kronos Longevity Research Institute
Organization:
Kronos Longevity Research Institute
Study Overview
Official Title:
Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The KEEPS is designed to explore the hypothesis that early initiation of hormone therapy in women who are at the inception of their menopause will decrease the rate of accumulation of atherosclerotic plaque indicating a likely delay in the onset of clinical cardiovascular disease The study is designed as a multicenter 4 year randomized clinical trial It will evaluate the effectiveness of of 045 mgday of oral conjugated equine estrogens or 50 mcgday of transdermal estradiol via skin patch changed weekly each in combination with cyclic oral micronized progesterone 200 mg daily for 12 days per month versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the accrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment A number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease and effects on cognition will also be studied The study will enroll a total of 720 women in 2005-6 with an anticipated completion of the trial in 2010
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB Protocol 20040792 | None | None | None |