A randomised, double blind, placebo controlled study to assess the effect of testosterone treatment on arterial stiffness in patients with type 2 diabetes, peripheral vascular disease and hypogonadism. - Testosterone Replacement in Diabetes and Vascular Disease
- Conditions
- Male Hypogonadism
- Registration Number
- EUCTR2005-003652-35-GB
- Lead Sponsor
- Barnsley Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 30
Male patients greater than 18 years of age.
Type 2 diabetes mellitus
Hypogonadism- serum testosterone less than 11 nmol/L on two samples
Peripheral Vascular Disease- ankle-brachial-pressure index <0.92 at baseline and symptoms.
Ability and agreement to comply with trial requirements after explanation in english language.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Current or previous breat or prostate malignancy.
Other active malignancy.
Raised prostate specific antigen level or abnormal rectal examination until cancer ruled out by specialist.
Treatment with testosterone in last three months.
Treatment with hormonallt active treatment apart from for diabetes in the last three months.
Involvement in another clinical trial in the last three months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method