Does Menopause Matter?

NCT ID: NCT00097994

Last Updated: 2014-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

732 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Menopause

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Rachel Hess

MD, MS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Hess, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

UPMC General Internal Medicine-Oakland

Locations

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UPMC General Internal Medicine Oakland

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/jama.287.5.591.

Reference Type BACKGROUND
PMID: 11829697 (View on PubMed)

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. doi: 10.1097/01.MLR.0000093479.39115.AF.

Reference Type BACKGROUND
PMID: 14583689 (View on PubMed)

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. doi: 10.1016/s0378-5122(02)00327-4.

Reference Type BACKGROUND
PMID: 12590012 (View on PubMed)

Albertazzi P, Purdie D. The nature and utility of the phytoestrogens: a review of the evidence. Maturitas. 2002 Jul 25;42(3):173-85. doi: 10.1016/s0378-5122(02)00024-5.

Reference Type BACKGROUND
PMID: 12161041 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23435023 (View on PubMed)

Other Identifiers

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1K23AG024254-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STRIDE

Identifier Type: -

Identifier Source: secondary_id

AG0010

Identifier Type: -

Identifier Source: org_study_id

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