Study Results
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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RECRUITING
NA
600 participants
INTERVENTIONAL
2018-04-17
2028-12-31
Brief Summary
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The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy.
Postmenopausal women with and without history of breast cancer will be recruited for the trial.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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oral hormonal therapy
Postmenopausal women who start with oral hormonal therapy (Progesteron + uterogestan) according to standard of care practice. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
transdermal hormonal therapy
Postmenopausal women who start with transdermal hormonal (Oestrogel + uterogestan) therapy according to standard of care practice. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
oral hormonal therapy + hysterectomy
Postmenopausal women who start with oral hormonal therapy (progesteron) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
transdermal hormonal therapy + hysterectomy
Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
oral hormonal therapy + IUD
Postmenopausal women who start with oral hormonal therapy (Progynova) according to standard of care practice and have already an intra-uterine device. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
transdermal hormonal therapy + IUD
Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and have an intra-uterine device. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
selective oestrogenreceptor modulators
Postmenopausal women who start with hormonal therapy according to standard of care practice and take selective oestrogenreceptor modulators (Nolvadex) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
aromatase inhibitors
Postmenopausal women who start with hormonal therapy according to standard of care practice and who taken aromatase inhibitors (Femara) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
Duavive
Postmenopausal women who start with hormonal therapy according to standard of care practice and who take duavive because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
Control
Postmenopausal women who don't start with hormonal therapy according to standard of care practice. At the first study visit blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
Interventions
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blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
Eligibility Criteria
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Inclusion Criteria
* 40 - 65 years
Exclusion Criteria
* thyroid dysfunction
* hypertension
* medical history of psychiatric comorbidity
* Alcohol and/or drug abuse
* medical history of neurologic symptoms with cognitive symptoms
40 Years
65 Years
FEMALE
Yes
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Herman Depypere, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent university hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EC/2018/0315
Identifier Type: -
Identifier Source: org_study_id
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