Clinical trial: Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism (NCT02159469)

Eligibility criteria:
Inclusion Criteria:

          -  Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism

          -  Total testosterone levels < 300 ng/dL at two qualification visits

          -  Patients in good general health

        Exclusion Criteria:

          -  Allergy to sesame or testosterone products

          -  BMI ≥ 40 kg/m2

          -  Hematocrit ≥ 52%

          -  History or current evidence of breast or prostate cancer

          -  Elevated PSA (Prostate-Specific Antigen) for age.

          -  Abnormal DRE (digital rectal examination)

          -  Obstructive uropathy of prostatic origin

          -  Poorly controlled diabetes

          -  Congestive heart failure

          -  Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to
             hospitalization, percutaneous coronary intervention, coronary artery bypass graft,
             uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid
             revascularization, endovascular procedure, or surgical intervention for peripheral
             vascular disease.

          -  History or current treatment of thromboembolic disease.

          -  Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks
             of screening.

          -  History of severe, untreated sleep apnea

          -  Subjects with any clinically significant medical condition which, in the opinion of
             the investigator, would make the subject an unsuitable candidate for enrollment in the
             study

          -  Positive serology for HIV, hepatitis B or hepatitis C

          -  Current evidence of drug or alcohol abuse.

          -  Skin conditions in injection site that could confound injection site assessments.

          -  Administration of other investigational compounds within one month of screening or 5
             half-lives of the investigational compound, whichever is longer).

          -  Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12
             months of screening.

          -  Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex
             hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of
             testosterone enanthate

          -  Considered or scheduled surgical or dental procedures associated with blood loss ≥500
             mL during study.

          -  Donation of plasma or blood within 56 days of screening or history of donation of > 50
             mL of blood or plasma within 3 months of screening.

          -  Donation of plasma or blood during study
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