The effect of testosterone therapy on angina threshold and atheroma in patients with stable angina - n/a
- Conditions
- hypogonadism and angina
- Registration Number
- EUCTR2005-000027-42-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 (<12nmol/L)
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.
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 BP< 100 mm Hg)
15. Severe, malignant, complicated, renovascular, secondary, or uncontrolled
hypertension (BP>180/114)
16. Hypercalcaemia
17. Nephrotic range proteinuria
18. Symptomatic obstructive sleep apnoea syndrome
19. With ECG abnormalities that preclude ST segment analysis (eg LBBB, AF)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method