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

NCT00131183 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-10-02

No results posted yet for this study

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

Interventions

DRUG

Nebido

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Kevin S Channer, MBChB (Hons) · Sheffield Teaching Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00131183 on ClinicalTrials.gov