Status:
COMPLETED
Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
Lead Sponsor:
Barnsley Hospital
Conditions:
Diabetes Mellitus
Peripheral Vascular Disease
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which a...
Eligibility Criteria
Inclusion
- Male patients greater than 18 years of age
- Type 2 Diabetes Mellitus
- Serum testosterone less than 11 nmol/L on two consecutive samples taken on different days
- Peripheral vascular disease as defined by ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
- Agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months of study
- Ability to give written informed consent after verbal and written explanation in the English Language
- Ability to comply with all study requirements
Exclusion
- Current or previous breast cancer
- Current or previous prostate cancer
- Raised prostate specific antigen or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion
- Severe symptoms of benign prostatic hypertrophy ('prostatism')
- Treatment with testosterone in the 3 months prior to the trial
- Investigational drug treatment in the 3 months prior to the trial
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00355537
Start Date
February 1 2006
End Date
December 1 2009
Last Update
March 30 2010
Active Locations (1)
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1
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2 EP