Menopause, PrematureNCT00173550
Perception and Attitude Toward Estrogen Therapy Among Surgically Menopausal Women
An observational study of Menopause, Premature and Hysterectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Menopause, Premature, Hysterectomy, Ovariectomy
- What is being tested?
- Hysterectomy and Bilateral salpingo-oophorectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age under 50
- Hysterectomy and bilateral oophorectomy
Who cannot join
- Unwilling to answer the questionnaires
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Department of Obstetrics and Gynecology
Taipei, Taipei, 100
Ruey-Jien Chen, MD, PhD, 886-2-2312-3456 ext. 5158, rjchen@ha.c.ntu.edu.tw
Ruey-Jien Chen, MD, PhD
About this study
Official title: Perception and Attitude Toward Estrogen Therapy Among Operated Women With Premature or Immature Menopause
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.
Read the 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.
- Conditions
- Menopause, Premature, Hysterectomy, Ovariectomy, Estrogen Replacement Therapy, Attitude, Perception
- Being tested
- Hysterectomy and Bilateral salpingo-oophorectomy
- Keywords
- Menopause, premature, Hysterectomy, Ovariectomy, Estrogen Replacement Therapy, Knowledge, Perception, Attitude
- Medical subject headings
- Menopause, Premature, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterectomy and Bilateral salpingo-oophorectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menopause, PrematureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Ruey-Jien Chen, MD, PhD, Principal investigator, Department or Obstetrics and Gynecology, National Taiwan university Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173550
- Sponsor's protocol ID
- 9461700710
- Other IDs
- NSC93-2314-B-002-162
- Status last verified
- Jul 2005
- First submitted
- 12 Sep 2005
- Last updated
- 23 Jan 2007
- Results posted
- No
Publications
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.
PubMed 15082697Levens 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. doi: 10.1016/j.ajog.2004.06.074.
PubMed 15343254
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception and Attitude Toward Estrogen Therapy Among Operated Women With Premature or Immature Menopause
- ClinicalTrials.gov ID
- NCT00173550
- Acronym / sponsor ID
- 9461700710
- Conditions
- Menopause, Premature, Hysterectomy, Ovariectomy, Estrogen Replacement Therapy, Attitude, Perception
- Keywords
- Menopause, premature, Hysterectomy, Ovariectomy, Estrogen Replacement Therapy, Knowledge, Perception, Attitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2004
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age under 50
- Hysterectomy and bilateral oophorectomy
Key exclusion criteria (1 listed)
- Unwilling to answer the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterectomy and Bilateral salpingo-oophorectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2007.
- Background: PubMed 15082697Anderson 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.
- Background: PubMed 15343254Levens 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. doi: 10.1016/j.ajog.2004.06.074.
- library of National taiwan University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruey-Jien Chen, MD, PhD principal investigator
Department or Obstetrics and Gynecology, National Taiwan university Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, Premature and Hysterectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruey-Jien Chen, MD, PhD (886-2-23123456 ext. 5158, rjchen@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00173550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2007.