Effect of Testosterone on the function of lining of small blood vessels in Type 2 diabetic patients with hypogonadism (low testosterone levels)

Phase 1

• Conditions: Hypogonadism and erectile dysfunction in patients with type 2 diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-020018-27-GB
• Lead Sponsor: Tameside Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

i. Type 2 Diabetes as judged by WHO criteria:(i)onset of diabetes mellitus after the age of 30 years (ii) blood glucose controlled by diet or drugs other than insulin, or insulin initiated after 2 years diagnosis of diabetes and (iii)no history of diabetic ketoacidosis. ii. Symptomatic Hypogonadism as defined by: Total testosterone below 10mmol/l Aging males' symptom score (AMS)above 36 iii. Hypogonadic men with or without erectile dysfunction. 1v. Age range 50-80 years v. Patients naive to testosterone treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

i. Patients with uncontrolled hypertension (BP>145/95 on treatment)or significant hypotension. (BP<100 systolic) ii. Current smokers. iii. Recent myocardial infarction (<6 months), unstable angina or ongoing chest pain, recent (within 6 months) cardiac intervention (e.g. angioplasty, stenting or CABG) or stroke. iv. Patients with clinical nephropathy ( 24 hr protein>0.5g or dipstix protein+) or moderate renal failure ( serum creatinine> 150umol/l) v. History of prostate cancer or suspicion of prostate cancer on clinical examination. vi. Androgen dependent carcinoma of the male mammary gland. vii. Liver tumors. viii. Hypersensitivity to NEBIDO or Levitra or any of their incipients. ix. Polycythemia. x. General systemic illness, including cardiac, renal or hepatic insufficiency. xi. Patients on nitrates will not be included in the Levitra arm. xii. History of loss of vision in one eye because of non arteric ischaemic optic neuropathy(NAION), regardlesss of whether this episode was in connection or not with previous PDE5 inhibitor exposure. xiii. Hereditary degenerative retinal disorders such as retinitis pigmentosa. xiv. Clinically significant chronic haematoligical disease which may lead to priapism. xv. Bleeding disorders. xvi. Significant active petic ulceration. xvii. Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are potent inhibitors of CYP 3A4. xviii. Concomitant use of of vardenafil with potent CYP 3A4 inhibitors ketoconazole and itaconazole (oral form) is contra-indicated in men older than 75 years. xix. Patients deemed unable to comply with the requirments of the protocol. xx. Patients who have been on testosterone treatment in the past.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified