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.
Conditions
Interventions
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
Sponsors
Dr. Chris Thompson
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 ;Primary end point(s): Percentage change in platelet aggregation in response to different agonists pre and post hormone replacement | — |
Countries
Ireland
Outcome results
None listed