Status:
COMPLETED
Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Schering-Plough
Conditions:
Angina Pectoris
Eligibility:
MALE
20+ years
Phase:
PHASE4
Brief 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 studi...
Detailed Description
In the past 4 years the investigators' research group has completed 2 studies on the effect of testosterone therapy on exercise induced coronary ischaemia (clinically manifest as angina pectoris). We,...
Eligibility Criteria
Inclusion
- 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
- 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 \[AF\])
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00131183
Start Date
September 1 2005
End Date
May 1 2008
Last Update
October 2 2019
Active Locations (1)
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1
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF