Clinical trial: A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations (NCT00702650)

Eligibility criteria:
Inclusion Criteria:

          -  Male subjects with a prior documented definitive diagnosis of hypogonadism as
             evidenced by previously documented:

               -  Hypothalamic, pituitary or testicular disorder or age related idiopathic
                  hypogonadism

               -  Screening serum testosterone of less than or equal to 300 ng/dL (based on the
                  average of two morning samples taken at least 30 minutes apart)

          -  Were currently receiving treatment for hypogonadism in accordance with approved
             labelling, or in the Investigator's opinion are eligible to receive such treatment

          -  Body Mass Index (BMI) < 35.0 kg/m^2

          -  Haemoglobin levels at screening greater than or equal to 11.5 g/dL

          -  Adequate venous access on left or right arm to allow collection of a number of samples
             by venipuncture

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

        Exclusion Criteria:

          -  Current use of long acting testosterone injectables such as Nebido®

          -  Any significant history of allergy and/or sensitivity to the drug products or their
             excipients, including any history of sensitivity to testosterone and/or sunscreens

          -  Any clinically significant chronic illness or finding on screening physical exam
             and/or laboratory testing that makes it undesirable for the Investigator to enrol the
             trial subject in the trial and/or that in the Investigator's opinion, would interfere
             with the trial objectives or safety of the subject

          -  Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal
             drug absorption

          -  Men with suspected reversible hypogonadism

          -  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 obstruction and International Prostate
                  Symptom Scores (IPSS) scores 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 > 51

               -  Untreated moderate to severe depression

          -  Men with clinically significant prostate exam (such as irregularities or nodules
             palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA)
             levels (>4 ng/mL), or age adjusted reference range of PSA values

          -  Current or history of drug or alcohol abuse (more than 4 standard drinks per day
             and/or abnormal liver function tests >2 times the upper limit of the normal range
             values)

          -  Men taking concomitant medications (prescribed, over-the-counter or complementary)
             that would affect sex hormone binding globulin (SHBG) or testosterone concentrations
             or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5
             alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for
             physiological replacement doses), estradiol

          -  Men involved in sport in which there is screening for anabolic steroids

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

          -  Men currently taking any investigational product, or have received an investigational
             product within 28 days prior to screening or 5 half-lives

          -  Any contraindication to blood sampling

          -  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