Does Menopause Matter?

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

National Institute on Aging (NIA)

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

Rachel Hess, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00097994

First received: December 1, 2004

Last updated: September 9, 2011

Last verified: September 2011

History of Changes

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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Does Menopause Matter?

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Estimated Enrollment:	720
Study Start Date:	December 2004
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Detailed Description:

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 to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women from the University of Pittsburgh's Division of General Internal Medicine Outpatient practice (GIMO)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refusal to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097994

Locations

United States, Pennsylvania
UPMC General Internal Medicine Oakland
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Institute on Aging (NIA)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Rachel Hess, MD, MSc

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thomas S, Ness RB, Thurston RC, Matthews K, Chang CC, Hess R. Racial differences in perception of healthy body weight in midlife women: results from the Do Stage Transitions Result in Detectable Effects study. Menopause. 2013 Mar;20(3):269-73. doi: 10.1097/GME.0b013e31826e7574.

Responsible Party:	Rachel Hess, MD, MS, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00097994 History of Changes
Other Study ID Numbers:	AG0010, 1K23AG024254-01, STRIDE
Study First Received:	December 1, 2004
Last Updated:	September 9, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Pittsburgh:

Menopause
Quality of Life
Health Services
Complementary Therapies

ClinicalTrials.gov processed this record on May 22, 2013

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