Clinical trial: A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males (NCT03335254)

Eligibility criteria:
Inclusion Criteria:

          -  Testosterone level <350 ng/dL, 10 am [± 2 hour] sample.

          -  Body mass index (BMI) <35.0 kg/m2 and weight ≥50 kg

        Exclusion Criteria:

          -  History of clinically significant renal, hepatic, neurologic, hematologic, endocrine,
             oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other
             condition.

          -  Significant gastrointestinal or malabsorption conditions.

          -  Any man in whom testosterone therapy is contraindicated including the following:

               1. Known or suspected carcinoma (or history of carcinoma) of the prostate,
                  clinically significant symptoms of benign prostatic hyperplasia, and/or
                  clinically significant symptoms of lower urinary obstruction and International
                  Prostate Symptom Score (IPSS) ≥19. A clinically significant digital rectal
                  examination of the prostate or clinically significant elevated serum PSA levels
                  (>4.0 ng/mL).

               2. Known or suspected carcinoma (or history of carcinoma) of the breast.

               3. Liver disease defined as alanine aminotransferase (ALT) or aspartate
                  aminotransferase (AST) >2 × upper limit of normal (ULN) or bilirubin >2 × ULN.

               4. Active deep vein thrombosis or thromboembolic disorder, or a documented history
                  of these conditions.

               5. Untreated sleep apnea.

               6. Hematocrit >50%.

               7. Untreated moderate to severe depression.

          -  Current use of long-acting testosterone or any of the testosterone esters injectables.

          -  Topical, oral, or injectable testosterone replacement therapy.

          -  Clinically significant changes in any medications (including dosages) or medical
             conditions in the 28 days before screening.

          -  Suspected reversible hypogonadism (e.g., leuprolide injection).

          -  Taking concomitant medications that affect testosterone concentrations or metabolism

          -  Uncontrolled diabetes (screening glycated hemoglobin [HbA1c] ≥9%).

          -  Donated blood or blood products or experienced significant blood loss within 90 days
             before dosing.

          -  Donated bone marrow within 6 months before dosing.

          -  History of drug or alcohol abuse in the last 6 months.

          -  Ingested St John's wort within 30 days of screening.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Entailment