Clinical trial: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two Period Cross Over Trial to Validate Patient-Reported Outcome Measures for Use in Men With Late Onset Hypogonadism (NCT00254553)

Eligibility criteria:
Inclusion Criteria:

        Men with late-onset hypogonadism who are either on testosterone treatment or naïve of
        treatment:

          -  have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e.
             with a positive score on the Androgen Deficiency in the Aging Male (ADAM)
             Questionnaire (a "yes" answer to questions 1 or 7 or any three other questions).

          -  morning total T levels of <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/l) on two separate days
             prior to randomization (after appropriate wash-out, if applicable).

          -  calculated free T <=0.074 ng/mL.

          -  at least 50 and at most 75 years of age.

          -  BMI of at least 18 kg/m^2 or at most 32 kg/m^2

        Inclusion Criteria for Normogonadal Men:

          -  morning total T levels <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/L).

          -  calculated free T <=0.074 ng/mL.

          -  at least 50 and at most 75 years of age.

          -  BMI of at least 18 kg/m^2 or at most 32 kg/m^2

        Exclusion Criteria:

          -  History or current diagnosis of prostate cancer or any clinically significant finding
             on prostate examination

          -  Severe obstructive symptoms of benign prostate hypertrophy

          -  Prostate specific antigen (PSA) levels greater than 4 ng/mL at screening

          -  History or current diagnosis of carcinoma of the breast

          -  Known chronic polycythemia and/or hematocrit greater than 50% at screening

          -  Treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level
             >=50 ng/mL)

          -  Hematological or biochemical values at screening outside the reference ranges
             considered as clinically significant in the opinion of the investigator

          -  clinically significant abnormal physical finding prior to randomization

          -  sensitive to trial medication or its components

          -  History or presence of hepatic or renal disorder considered as clinically relevant in
             the opinion of the investigator.

        Exclusion Criteria for Normogonadal Men:

          -  Presence or previous diagnosis of androgen deficiency.

          -  Previous or present use of testosterone preparations

          -  Use of medication within the 12 weeks prior to the visit that may interfere with the
             objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g.,
             gonadotropins, ACTH, STH, Gn-RH agonists and antagonists, etc.); sex steroid

          -  Any other disease that in the opinion of the investigator might compromise or confound
             the subject's symptomatology (e.g., presence of clinically significant depression or
             other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular
             and cerebrovascular diseases, etc.)
Male
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 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