Clinical trial: NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers (NCT00647868)

Eligibility criteria:
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.
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction