Clinical trial: A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations (NCT00857454)

Eligibility criteria:
Inclusion Criteria:

          -  Hypogonadal males with a qualifying general medical health who have Completed the
             MTE08 trial up to and including Day 120/121 in a compliant manner

          -  Were able to communicate with the trial staff, understand the Trial Information Sheet
             and sign the Written Informed Consent Forms; were willing to follow the Protocol
             requirements and comply with Protocol restrictions and procedures

        Exclusion Criteria:

          -  Any clinically significant chronic illness or finding and/or laboratory testing that
             would interfere with the trial objectives or safety of the subject

          -  Any man in whom testosterone therapy was contraindicated, which included those with:

               -  Known or suspected carcinoma (or history of carcinoma) of the prostate or
                  clinically significant symptoms of benign prostatic hyperplasia and/or clinically
                  significant symptoms of lower urinary obstructions and with a International
                  Prostate Symptoms Score (IPSS) score of greater than or equal to 19

               -  Known or suspected carcinoma (or history of carcinoma) of the breast

               -  Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver
                  function tests >2 times the upper limit of the normal range values

               -  Active deep vein thrombosis, thromboembolic disorders or a documented history of
                  these conditions

               -  Current significant cerebrovascular or coronary artery disease

               -  Untreated sleep apnoea

               -  Haematocrit of >54%

               -  Untreated moderate to severe depression

          -  Men with clinically significant prostate exam or clinically significant elevated serum
             Prostate Specific Antigen (PSA) level (> 4 ng/mL) or age adjusted reference range of
             PSA values

          -  Men taking concomitant medications (prescribed, over-the-counter or complementary)
             that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations
             (excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as
             warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha
             reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for
             physiological replacement doses), estradiol

          -  Men with uncontrolled diabetes (Hemoglobin A1c [HbA1c] greater than or equal to 10%)

          -  Subjects intending to have any surgical procedure during the course of the trial

          -  Subjects with a partner of child bearing potential who are not willing to use adequate
             contraception for the duration of the trial

          -  Subjects whose partners are pregnant
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