Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
CompletedPhase 4NCT00131183
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Effect of Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
- Conditions
- Interventions
- Drug: Nebido
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Collaborators
- Schering-Plough
- Start date
- 2005-09
- Primary completion
- 2008-05
- Sex
- Male
- Age range
- from 20 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 \[AF\])
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00131183