Hormone Therapy Effects on CVD Risk Factors

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00006313
Study type	Observational
Source	National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status	Completed
Phase	N/A
Start date	June 1999
Completion date	June 2000

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.