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Hormone Therapy Effects on CVD Risk Factors

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006313
First received: September 28, 2000
Last updated: May 12, 2016
Last verified: September 2002
  Purpose
To conduct extended analysis of the Postmenopausal Estrogen/Progestins Intervention PEPI trial database to address questions related to cardiovascular disease risk factor response and the possible determinants of this response.

Condition
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Postmenopause

Study Type: Observational
Study Design: Time Perspective: Retrospective

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1999
Study Completion Date: June 2000
Detailed Description:

BACKGROUND:

Cardiovascular disease is the leading cause of death among postmenopausal women. Growing evidence exists that hormone replacement therapy (HRT) may reduce cardiovascular disease and mortality. This has led to the use of postmenopausal HRT for primary prevention of heart disease, however it remains unresolved which women are likely to benefit most from this clinical approach. This is a complicated question because many potential mechanisms are involved by which hormone therapy (HRT) may confer cardioprotection. The Postmenopausal Estrogen/Progestins Intervention (PEPI) trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors (e.g. lipids, blood pressure, insulin/glucose, hemostasis factors). The trial was well conducted; its data have been thoroughly edited and have yielded a series of important publications. To date, however, publications have focused on average effects without a thorough exploration of the range of, and interplay among, the various effects across the 875 enrolled in the trial.

DESIGN NARRATIVE:

The study extended the analysis of PEPI data by: 1) characterizing the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease (lipids/lipoproteins, blood pressure, insulin/glucose, hemostasis factors); 2) examining the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes (symptomatology, bone, endometrial); 3) examining clinical and demographic factors that may affect these relationships and, in doing so, characterizing women who may vary with respect to their "sensitivity" to the separate effects of estrogen and progestin therapy; 4) examining closely patterns of adherence and their relationship to response. An experienced team of statisticians/epidemiologists conducted and planned to publish results from these analyses.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00006313     History of Changes
Other Study ID Numbers: 921  R03HL062429 
Study First Received: September 28, 2000
Last Updated: May 12, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 23, 2016