NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

Inclusion Criteria for hypogonadal subjects: * men with primary or secondary hypogonadism and testosterone serum levels below 300 ng/dl \[= 10.4 nmol/l\], on two occasions within a period of one month before inclusion; * age: 20-60 years; * normal thyroid function, physiologic prolactin concentration; * normal otorhinolaryngologic examination (ENT examination); * normal 24-h activity-rest pattern; * written Informed Consent. Exclusion Criteria for hypogonadal subjects: * significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months); * history of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea; * sleeping disorders; * abnormal prostate examination indicative for prostate cancer or elevated serum PSA levels (PSA \< 2.5 ng/ml for subjects \< 40 years of age and \< 4 ng/ml for subjects \>= 40 years of age); * history of cancer, especially breast, prostate or testicular tumor; excluding skin cancer; * history of severe or multiple allergies, severe adverse drug reaction or leucopenia. A known hypersensitivity to lignocaine/lidocaine or all surgical dressings which may be used in the study procedures; * history of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies; * the patient is a heavy smoker currently smoking \> 20 cigarettes per day or smoking history \>10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year); * regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the initial-dose administration and for the duration of the study; * history or current evidence of abuse of alcohol or any drug substance, licit or illicit; or positive urine drug and alcohol screen for drugs of abuse and alcohol; * treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study; * testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular); * current or recent (previous 4 weeks) use of over the counter male enhancement products; * use of nasal decongestants and nasal corticosteroids; * shift work; * transmeridian flights within 1 month before Day 1 of the study; * poor compliers or those unlikely to attend; * intake of any drug as part of a research study within 30 days of initial-dose administration in this study and throughout the study; * blood donation within the 12-week period before the initial study dose. Inclusion criteria for eugonadal subjects: * men with testosterone serum levels above 300 ng/dl \[= 10.4 nmol/l\] on two occasions within a period of one month before inclusion; * age: 20-60 years; * normal thyroid function, physiologic prolactin concentration; * normal 24-h activity-rest pattern; * written Informed Consent. Exclusion criteria for eugonadal subjects: * significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months); * history of hypogonadism; * sleeping disorders; * treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study; * testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular); * current or recent (previous 4 weeks) use of over the counter male enhancement products; * shift work; * transmeridian flights within 1 month before Day 1 of the study; * the patient is a heavy smoker currently smoking \> 20 cigarettes per day or smoking history \>10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year); * regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the 24-h blood sampling day; * blood donation within the 12-week period before the 24-h blood sampling day.