Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk?

Conditions: 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.

Registration Number: EUCTR2005-005613-38-IE

Lead Sponsor: Dr. Chris Thompson

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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.;Secondary Objective: To assess whether sex hormone replacement has measurable effects on markers of platelet function and endothelial function<br>To assess whether growth hormone replacement has measurable effects on markers of platelet function and endothelial function<br>To assess for measurable differences in platelet function between genders <br>To quantify oestrogen receptor numbers pre and post hormone replacement<br>;Primary end point(s): Percentage change in platelet aggregation in response to different agonists pre and post hormone replacement

Secondary Outcome Measures