Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00006407 |
| Other study ID # |
932 |
| Secondary ID |
R01HL065531 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 12, 2000 |
| Last updated |
March 15, 2016 |
| Start date |
September 2000 |
| Est. completion date |
July 2004 |
Study information
| Verified date |
March 2005 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To investigate the relationship between endogenous estrogen and androgen levels and risk of
coronary heart disease among postmenopausal women in the Women's Health
Initiative-Observational Study (WHI-OS).
Description:
BACKGROUND:
The role of endogenous gonadal hormones in the etiology of atherosclerotic disease needs
clarification. Previous studies of women have been small, rarely prospective, and had other
methodological problems. Results have been inconsistent. Observational and clinical trial
data on exogenous hormones, also inconsistent, are probably irrelevant to endogenous
hormonal effects.
On the other hand, despite hormonal differences being evoked as the reason for women having
less atherosclerotic disease than men, it is not apparent from existing data that
between-person variability in endogenous hormones is likely to be a strong risk factor for
atherosclerotic disease in women. Furthermore, the atherosclerotic process begins early in
life, and postmenopausal hormone differences are only one aspect of possible hormonal
effects on disease. Nevertheless, this study has the potential to provide important new
information on the role of endogenous hormones on atherosclerotic disease in postmenopausal
women.
DESIGN NARRATIVE:
The study used a nested-case control design to measure baseline sex steroid hormone levels
(serum total and free estradiol, estrone sulfate, total and free testosterone,
dehydroepiandrosterone sulfate) and sex hormone binding globulin to determine whether these
predicted subsequent risk of coronary heart disease (CHD). A total of 350 case subjects and
350 control subjects were selected from women who were free from cardiovascular disease and
cancer at study entry and were not using hormone replacement therapy at baseline. Cases were
those women who subsequently developed a documented myocardial infarction or underwent
coronary artery revascularization (N=350), while control subjects were selected from study
participants who remained free from CHD during follow-up. Controls were matched 1:1 for age,
ethnicity, smoking and follow-up time. The study also examined correlations between sex
steroid hormone levels and other previously funded analyses of biomarkers, including
thrombotic and inflammatory markers, lipoproteins, fasting glucose and insulin. Detailed
baseline data including anthropometrics and behavioral factors allowed control for
confounding.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
