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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005435
Other study ID # 4362
Secondary ID R29HL046283
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date July 1991
Est. completion date June 1997

Study information

Verified date June 2000
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 determine the combined effects of hostility, harassment, lipids, and oral contraceptive (0C) use on physiological responses in young and middle-aged premenopausal women.


Description:

BACKGROUND:

Preliminary findings already have shown that, in contrast to women with low scores on the Cook and Medley Hostility (Ho) scale, women with high Ho scores exhibit greater cardiovascular changes to harassment. Additional findings have suggested that oral contraceptive (0C) use may also be associated with increased behaviorally-induced physiological changes, especially in low Ho women. Similarly, higher levels of total serum cholesterol (TSC) have been positively associated with greater stress-induced neurohormonal changes in middle-aged men with high Ho scores.

DESIGN NARRATIVE:

Assessment of autonomic activity took place in the laboratory and during a 24 hour ambulatory measurement period. Hostility was measured with the Cook and Medley Hostility scale. The laboratory assessment helped to determine if high hostility women responded to harassment with greater cardiovascular and neurohormonal changes than low hostility women, and if this relationship was altered by 0C use, lipids, and age. The ambulatory assessment of autonomic activity allowed an exploration of the responses of high and low hostility subjects to daily-life stressors. Several hypothesis were explored: 1) Did harassment produce neuroendocrine as well as cardiovascular hyperreactivity in young women, and did this hyperreactivity generalize from laboratory to real-life? 2) Were the harassment-induced cardiovascular and neuroendocrine changes in young women also present in middle-aged women? 3) To what extent did 0C use modulate the cardiovascular and neuroendocrine responses to harassment in young women, and was 0C use also altering the hostility--related associations between lipids and reactivity? 4) Were the differential lipid-reactivity associations observed in middle-aged men as a function of high and low hostility scores present in women, and, if so, were they modulated by age?

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 1997
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Harralson TL, Suarez EC, Lawler KA. Cardiovascular reactivity among hostile men and women: the effects of sex and anger suppression. Womens Health. 1997 Summer;3(2):151-64. — View Citation

Suarez EC, Bates MP, Harralson TL. The relation of hostility to lipids and lipoproteins in women: evidence for the role of antagonistic hostility. Ann Behav Med. 1998 Spring;20(2):59-63. — View Citation

Suarez EC, Harlan E, Peoples MC, Williams RB Jr. Cardiovascular and emotional responses in women: the role of hostility and harassment. Health Psychol. 1993 Nov;12(6):459-68. — View Citation

Suarez EC. Relations of trait depression and anxiety to low lipid and lipoprotein concentrations in healthy young adult women. Psychosom Med. 1999 May-Jun;61(3):273-9. — View Citation

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