Male Hypogonadism
Conditions
Interventions
Trade Name: Sustanon 250
Product Name: Sustanon 250
Product Code: Sustanon 250
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administr
Sponsors
Barnsley Hospital NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the effect of twelve weeks of testosterone replacement, given as Sustanon 250 IM injection, on arterial stiffness measured by ultrasound derived stiffness index beta of the femoral artery in men with hypogonadism, type 2 diabetes mellitus and peripheral vascular disease (the study population).;Secondary Objective: To test the effect of testosterone, given as above, on intima-media thickness of the femoral artery in the study population To test the effect of testosterone, given as above, on peripheral vascular disease as measured by transcutaneous oximetry of the foot and ankle-brachial-pressure index in the study population. To test the effect of testosterone, given as above, on vascular risk factors (eg blood pressure, cholesterol, weight) in the study population.;Primary end point(s): Change in the stiffness index beta of the femoral artery in men with hypogonadism, type 2 diabetes mellitus and peripheral vascular disease (the study population) after twelve weeks of testosterone replacement, given as Sustanon 250 IM injection compared with placebo. | — |
Countries
United Kingdom
Outcome results
None listed