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

NCT00131183 | Completed Phase 4

• 1 other identifier: STH13979
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Angina Pectoris

Keywords

Angina Pectoris; Arteriosclerosis; Testosterone

Outcome Measures

Primary Outcomes (1)

• Change in time to ST- segment depression of > 1mm during exercise testing

Secondary Outcomes (7)

• Change in carotid atheroma assessed by media:intimal thickness ratio of the carotid artery

• Change in time to exercise induced chest pain as judged by a single observer

• Change in frequency of attacks of angina as recorded in the patients' angina diary

• Change in high sensitivity C reactive protein (hs-CRP)

• Change in scores on the Seattle Angina Questionnaire (SAQ)

Interventions

Nebido DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Schering-Plough: collaborator

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Angina Pectoris; Arteriosclerosis

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases

Study Officials

• Kevin S Channer, MBChB (Hons)

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2005
• First Posted: August 17, 2005
• Study Start: September 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 2, 2019

Record last verified: 2006-09

Locations

GB (1)