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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00173550
Other study ID # 9461700710
Secondary ID NSC93-2314-B-002
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated January 22, 2007
Start date August 2004

Study information

Verified date July 2005
Source National Taiwan University Hospital
Contact Ruey-Jien Chen, MD, PhD
Phone 886-2-23123456
Email rjchen@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

The aim of this study is to survey patient’s cognition and attitude about health-related quality of life, use of estrogen, experience of menopausal syndrome, compliance of medication, experience, and satisfaction for women who underwent hysterectomy and bilateral oophorectomy before menopause.


Description:

The cognition and attitude of menopausal women toward hormone replacement could have been changed since the report from WHI in July 2002. Previously, many women used hormone replacement to prevent cardiovascular disease and osteoporosis. Recently, the use has been challenged, exaggerated, and also discussed both in media press and academic meetings. Many women dare not to use them. The women who underwent hysterectomy and bilateral salpingo-oophorectomy before menopause may immediately face the problems caused by deficiency of female sex hormone. For this group of women, as yet there is no conclusion about whether the women should take hormone replacement therapy for a long time to osteoporosis, cardiovascular disease and other chronic disease. The arm for this study from WHI is not closed yet. While the women in our area might have been influenced by this report and have changed their mind. It is essential for us to make a clear understanding about the cognition and attitude for hormone replacement therapy for women who underwent hysterectomy and bilateral salpingo- oophorectomy. Therefore, it may be a pioneer study and worthwhile to do this study. Data from a medical center from 2000 to 2004 will be examined for evidence of bilateral oophorectomy & hysterectomy. The cause for the surgery will be confirmed by pathological findings. These women who were under 50 years of age will be candidate of the study. The women will be interviewed about their beliefs, and cognition, regarding their quality of life and health risks as well as their opinion on menopause and hormone replacement therapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Age under 50

- Hysterectomy and bilateral oophorectomy

Exclusion Criteria:

- Unwilling to answer the questionnaires

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional


Intervention

Procedure:
Hysterectomy and Bilateral salpingo-oophorectomy


Locations

Country Name City State
Taiwan National Taiwan University Hospital Department of Obstetrics and Gynecology Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O'Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12. — View Citation

Levens E, Williams RS. Current opinions and understandings of menopausal women about hormone replacement therapy (HRT)-the University of Florida experience. Am J Obstet Gynecol. 2004 Aug;191(2):641-6; discussion 646-7. — View Citation

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