Male Type 2 diabetics with symptomatic testosterone deficiency and confirmed low levels of serum testosterone
Conditions
Interventions
Trade Name: NEBIDO
Product Name: NEBIDO
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intramuscular use
Sponsors
Dr G I Hackett
Eligibility
Inclusion criteria
Inclusion criteria: •Inclusion Criteria 1. Men over 18 with type 2 diabetes previously identified with a morning total testosterone of 12nmol/L or less or calculated free testosterone of 250 pmol/L or less. In line with ISSM criteria enyty citeria will be calculated from the mean of 2 measurements, at screening and baseline. 2. Symptoms of hypogonadism as defined by the clinician 3. Patients giving written informed consent. 4. Medication for erectile dysfunction at screening is allowed, but the pattern of use should be maintained. Commencement of PDE5 inhibitor, intracavernosal injection, intra-urethral alprostadil or vacuum device would necessitate withdrawal. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Any form of testosterone or oestrogen therapy. 2. Any contraindication to use of NEBIDO. 3. Patients taking anticoagulants. e.g warfarin 4. Patients taking anticonvulsants. 5. Current or past history of prostate cancer. 6. Clinically significantly raised PSA at baseline in the opinion of the investigator. 7 Patients with medical or psychological issues that, in the view of the physician, would warrant exclusio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Primary Objectives To study the efficacy of 1000mg of Nebido, compared with placebo administered as per the product licence on standard diabetes parameters in a UK primary care type 2 diabetes population and symptomatic testosterone deficiency syndrome (TDS). • ;Secondary Objective: Secondary objectives To evaluate the efficacy of 1000mg of Nebido administered as per the product licence on sexual function, depression, and well-being in a UK primary care type 2 diabetic population and symptomatic testosterone deficiency syndrome (TDS. ;Primary end point(s): Primary Efficacy measures Changes in HbA1c from baseline. • Secondary efficacy measures Lipid Profile LDL cholesterol, triglycerides, Waist circumference, BMI. Blood pressure HOMA – A standardized measure of insulin resistance. IIEF (International Index of Erectile Function) HADS ( Hospital Anxiety and Depression Scale) . AMSS (Ageing Male Symptom Score) | — |
Countries
United Kingdom
Outcome results
None listed