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Does Menopause Matter? - Article


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Indoor Environmental Quality




Clinical Trial: Does Menopause Matter?

This study is currently recruiting patients.

Sponsors and Collaborators: National Institute on Aging (NIA)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Institute on Aging (NIA)

Purpose

The purpose of this study is to follow a woman’s progression through menopause in order to examine the effects on health related quality of life and use of health care resources, and to understand how women are using alternative therapies.

Condition
Menopause
Quality of Life

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Psychosocial, Longitudinal, Defined Population, Prospective Study

Further Study Details: 

Expected Total Enrollment:  720

Study start: December 2004;  Expected completion: July 2009
Last follow-up: January 2009;  Data entry closure: January 2009

Menopause affects every woman as she ages, yet every woman’s experience is different. We are seeking to enroll 720 women from the University of Pittsburgh’s Division of General Internal Medicine Outpatient practice (GIMO) at all stages of menopause (pre-, peri-, and post-menopausal), between 40 and 65 years old. They will be followed for 5 years as they progress through menopause.

Women will complete yearly questionnaires during their usual doctor’s visit (or by phone or online if necessary) regarding general health, menopause and menopausal symptoms, health related quality of life, traditional and alternative therapy use, social support, and attitudes towards menopause and aging.

We will combine this information with information from women’s medical charts to look at how menopause and health related quality of life impact the use of health care resources. Additionally, some women may be asked about the use of health care resources, such as doctor’s visits, hospitalizations and lab tests.

Eligibility

Ages Eligible for Study:  40 Years   -   65 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Women ages 40-65
  • Patient in the University of Pittsburgh General Internal Medicine Oakland Practice
  • Able to complete our Functional Assessment Screening Tablet (a touch-screen survey)

Exclusion Criteria:

  • Refusal to participate

Location and Contact Information

Rachel Hess, MD, MSc      412-692-2025    hessr@upmc.edu

Pennsylvania
      UPMC General Internal Medicine Oakland, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Rachel Hess, MD, MSc  412-692-2025    hessr@upmc.edu 
Rachel Hess, MD, MSc,  Principal Investigator
Wishwa Kapoor, MD, MPH,  Sub-Investigator
Karen Matthews, PhD,  Sub-Investigator
Roberta Ness, MD, MPH,  Sub-Investigator

Study chairs or principal investigators

Rachel Hess, MD, MSc,  Principal Investigator,  UPMC General Internal Medicine-Oakland   

More Information

Publications

Hlatky MA, Boothroyd D, Vittinghoff E, Sharp P, Whooley MA; Heart and Estrogen/Progestin Replacement Study (HERS) Research Group. Quality-of-life and depressive symptoms in postmenopausal women after receiving hormone therapy: results from the Heart and Estrogen/Progestin Replacement Study (HERS) trial. JAMA. 2002 Feb 6;287(5):591-7.

Avis NE, Ory M, Matthews KA, Schocken M, Bromberger J, Colvin A. Health-related quality of life in a multiethnic sample of middle-aged women: Study of Women's Health Across the Nation (SWAN). Med Care. 2003 Nov;41(11):1262-76.

Gambacciani M, Ciaponi M, Cappagli B, Monteleone P, Benussi C, Bevilacqua G, Genazzani AR. Effects of low-dose, continuous combined estradiol and noretisterone acetate on menopausal quality of life in early postmenopausal women. Maturitas. 2003 Feb 25;44(2):157-63.

Albertazzi P, Purdie D. The nature and utility of the phytoestrogens: a review of the evidence. Maturitas. 2002 Jul 25;42(3):173-85. Review.

Study ID Numbers:  AG0010; 1K23AG024254-01; STRIDE
Record last reviewed:  March 2005
Last Updated:  March 1, 2005
Record first received:  December 1, 2004
ClinicalTrials.gov Identifier:  NCT00097994
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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January 7, 2009



Page Updated: November 22, 2004
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