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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-005613-38-IE |
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Date of registration:
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06/01/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk?
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Scientific title:
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Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk? |
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Date of first enrolment:
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31/05/2006 |
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Target sample size:
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50 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005613-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: yes
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Ireland
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Male or female with hypopituitarism with proven sex hormone and growth hormone deficiency
Aged 18 years or more
Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
Willing to give informed consent prior to participation in the trial (i.e. prior to any trial specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Currently on Aspirin/Plavix in previous 14 days
On NSAIDs in previous 14 days
INR >1.4
On Statin therapy
Pregnancy
Diabetes Insipidus
Known, past or suspected breast cancer.
Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
Undiagnosed genital bleeding.
Untreated endometrial hyperplasia.
Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism).
Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction).
Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal.
Known hypersensitivity to the active substances or any of the excipients
Porphyria.
Prader-Willi Syndrome
Known or suspected Prostate cancer
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Hypopituitarism refers to decreased secretion of pituitary hormones, which can result from diseases of the pituitary gland or from diseases of the hypothalamus, which cause diminished secretion of hypothalamic releasing hormones, thereby reducing secretion of the corresponding pituitary hormones.
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Intervention(s)
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Trade Name: Trisequens
Pharmaceutical Form: Film-coated tablet
Trade Name: Testogel
Pharmaceutical Form: Gel
Trade Name: Genotropin MiniQuick
Pharmaceutical Form: Powder and solvent for solution for injection
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Primary Outcome(s)
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Main Objective: To compare the effects of sex hormone replacement therapy to growth hormone replacement in the hypopituitary population using markers of platelet and endothelial function
To characterise differences in platelet hyperreactivity between genders in a dose dependent manner and a significant difference in platelet gene expression between genders and following replacement with HRT.
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Secondary Objective: To assess whether sex hormone replacement has measurable effects on markers of platelet function and endothelial function
To assess whether growth hormone replacement has measurable effects on markers of platelet function and endothelial function
To assess for measurable differences in platelet function between genders
To quantify oestrogen receptor numbers pre and post hormone replacement
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Primary end point(s): Percentage change in platelet aggregation in response to different agonists pre and post hormone replacement
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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