Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia:

• Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. The investigators' earlier studies were limited to 3 months.

• Does testosterone therapy in men affect the levels of measurable atheroma? There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma, although there is abundant evidence in animals to suggest a potential improvement.

This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease. The primary endpoint is the change in time to ST- segment depression of > 1mm during exercise testing.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: Schering-Plough
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Males over 20 years of age

• Stable, chronic angina pectoris for > 1 month

• ST- segment depression of > 1mm within 12 minutes of the Bruce protocol

• Willing and able to give informed consent and comply with the study protocol

• Serum testosterone (< 12nmol/L)

Exclusion Criteria:

• 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

• Contraindication to treatment with Nebido®.

• Organic hypothalamic-pituitary pathology

• Prostate specific antigen (PSA) >= 4ng/ml

• Severe symptomatic benign prostatic hyperplasia

• Patients actively or potentially trying to start a family or requiring fertility treatment

• Suspicion of, current, or past history of breast or prostatic carcinoma

• Myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in the last three months.

• Significant hepatic, respiratory, haematological or renal disease

• Haematocrit > 50% at entry to the study (i.e. screening visit/visit 1)

• History of significant arrhythmia, Wolff-Parkinson-White (WPW) syndrome, > 1st degree heart block, or cerebrovascular accident (CVA) within the last three months

• History of drug or alcohol abuse

• Receiving other trial drugs within 12 weeks

• Hypotension (systolic blood pressure [BP] < 100 mm Hg)

• Severe, malignant, complicated, renovascular, secondary, or uncontrolled hypertension (BP > 180/114)

• Hypercalcaemia

• Nephrotic range proteinuria

• Symptomatic obstructive sleep apnoea syndrome

• Electrocardiogram (ECG) abnormalities that preclude ST- segment analysis (eg left bundle branch block [LBBB], atrial fibrillation [AF])