Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01084369
Eligibility Criteria:
Inclusion Criteria:
* 40 male patients with type 2 diabetes mellitus.
* T2DM as judged by WHO criteria:
* onset of diabetes mellitus after the age of 30 years
* blood glucose controlled by diet or drugs other than insulin, or insulin initiated after 2 years diagnosis of diabetes
* no history of diabetic ketoacidosis.
* Symptomatic Hypogonadism as defined by:
* Total testosterone below 10 nmol/l
* Aging males' symptom score (AMS) above 36.
* Hypogonadic men with erectile dysfunction
* Age range- 50-80 years
Exclusion Criteria:
* Patients with uncontrolled hypertension (BP\>145/95 on treatment) or significant hypotension. (BP\<100 systolic)
* Current smokers
* 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.
* Patients with clinical nephropathy (24 hr protein \>0.5 g or urine protein +) or moderate renal failure (serum creatinine \>150 micromol/l).
* History of prostate cancer or suspicion of prostate cancer on clinical examination
* Androgen dependent carcinoma of the male mammary gland
* Liver tumours
* Hypersensitivity to NEBIDO or LEVITRA
* Polycythaemia
* General systemic illness, including cardiac, renal or hepatic insufficiency
* Patients on nitrates will not be included in the Levitra arm.
* History of loss of vision in one eye because of non arteritic ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
* Hereditary degenerative retinal disorders such as retinitis pigmentosa.
* Clinically significant chronic haematological disease which may lead to priapism
* Bleeding disorders
* Significant active peptic ulceration.
* Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are potent inhibitors of CYP 3A4
* Concomitant use of vardenafil with potent CYP 3A4 inhibitors ketoconazole and itraconazole (oral form) is contra-indicated in men older than 75 years.
* Patients deemed unable to comply with the requirements of the protocol.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT01084369
Study Brief:
Protocol Section:
NCT01084369