Clinical trial: Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men (NCT00467870)

Eligibility criteria:
Inclusion Criteria:

          -  Male with primary or secondary hypogonadism at least 18 years of age and for study
             part C2 weighs ≥143.3 lb (≥65 kg)

          -  Morning screening serum testosterone concentration <300 ng/dL

        Exclusion Criteria:

          -  American Urological Association (AUA) Symptom Score ≥15 or significant prostatic
             symptoms

          -  History of carcinoma, tumors or induration of the prostate or the male mammary gland
             including suspicion thereof

          -  Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the
             prostate (size >75 cm3 as measured by transrectal ultrasonography)

          -  Past or present liver tumors or acute or chronic hepatic disease with impairment of
             liver function; liver function tests (alanine aminotransferase [ALT], aspartate
             aminotransferase [AST]) exceeding 1.5 times upper limit of normal

          -  History of deep vein thrombosis in the past 5 years or any history of cerebrovascular
             accident

          -  Severe acne

          -  Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm
             Hg) or coronary heart disease not stabilized by therapy as assessed by the
             investigator

          -  Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes
             mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C)
             level is >9%

          -  Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7
             days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit
             and throughout the study (exclusive of administered study drug)

          -  Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by
             any application method within the 28 days prior to first administration of study drug
             and throughout the study (exclusive of administrated study drug)

          -  Medication with substances which might interfere with testosterone metabolism within
             28 days before the first administration of study drug

          -  History of sleep apnea Insulin-dependent diabetes mellitus

          -  Use of steroidal anabolic drugs or supplements by any application method within the
             28-days prior to the first administration of the study drug and throughout the study
             (exclusive of the administered study drug)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Entailment