Perception and Attitude Toward Estrogen Therapy Among Sur... | NCT00173550

Studies
Perception and Attitude Toward Estrogen Therapy Among Surgically Menopausal Women

NCT00173550

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jan 23, 2007Estimated

Enrollment

200

Phase

Not provided

Conditions

Menopause, Premature
Hysterectomy
Ovariectomy
Estrogen Replacement Therapy
Attitude
Perception

Interventions

Hysterectomy and Bilateral salpingo-oophorectomy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NSC93-2314-B-002-162

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2007

Last Update Posted Date

Jan 23, 2007Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Hysterectomy and Bilateral salpingo-oophorectomy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age under 50
Hysterectomy and bilateral oophorectomy

Exclusion Criteria:

Unwilling to answer the questionnaires

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruey-Jien Chen, MD, PhD	Contact	886-2-23123456	5158	rjchen@ha.mc.ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Ruey-Jien Chen, MD, PhD	Department or Obstetrics and Gynecology, National Taiwan university Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital Department of Obstetrics and Gynecology	Recruiting	Taipei	Taipei	100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15082697	Background	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. doi: 10.1001/jama.291.14.1701.
15343254

ID	Term
D008594	Menopause, Premature
D001519	Behavior

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative