hypogonadism and angina
Conditions
Interventions
Trade Name: Nebido
Product Name: Nebido
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Testosterone undecanoate
Concen
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: PATIENT SELECTION CRITERIA Patients will be recruited from those under the care of consultant cardiologists within the North Trent network. . Inclusion Criteria. 1. Males over 20 years of age 2. With stable, chronic angina pectoris for > 1 month 3. With S-T segment depression of > 1mm within 12 minutes of the Bruce protocol 4. Willing and able to give informed consent and comply with the study protocol 5. Serum testosterone (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria. 1. Use of androgen therapy or anabolic steroids within 6 months of entry into the study (i.e. screening visit/visit 1) or concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone 2. Contraindication to treatment with Nebido®. 3. Organic hypothalamic-pituitary pathology 4. Prostate specific antigen (PSA) ≥4ng/ml 5. Severe symptomatic benign prostatic hyperplasia 6. Patients actively or potentially trying to start a family or requiring fertility treatment 7. Suspicion of, current, or past history of breast or prostatic carcinoma 8. MI, CABG or PTCA in the last three months 9. Significant hepatic, respiratory, haematological or renal disease 10.Haematocrit >50% at entry to the study (i.e. screening visit/visit 1) 11.History of significant arrhythmia, WPW syndrome, or >1st degree heart block. CVA within the last three months 12. History of drug or alcohol abuse 13. Receiving other trial drugs within 12 weeks 14. Hypotension (systolic BP180/114) 16. Hypercalcaemia 17. Nephrotic range proteinuria 18. Symptomatic obstructive sleep apnoea syndrome 19. With ECG abnormalities that preclude ST segment analysis (eg LBBB, AF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the anti-anginal effect of testosterone therapy in men with coronary ischaemia persist in the long term;Secondary Objective: Does testosteone therapy in men affect the levels of measurable atheroma?;Primary end point(s): Change in angina threshold as determined by exercise testing at the end of one year of testosterone therapy | — |
Countries
United Kingdom
Outcome results
None listed