Clinical trial: A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (NCT02722278)

Eligibility criteria:
Inclusion Criteria:

          1. Man 18 to 65 years of age, inclusive, with hypogonadism as defined by 2 AM total T
             values of <300 ng/dL drawn on 2 separate days ([approximately 7 days apart]).

          2. Adequate venous access

          3. Must be naïve to androgen-replacement therapy or washed out of prior androgen
             replacement therapies; willing to cease current T treatment or currently not be taking
             T treatment. Subjects must remain off all forms of T, except for dispensed study drug,
             throughout the entire study.

          4. Subjects on replacement therapy for hypopituitarism or multiple endocrine deficiencies
             must be on stable doses of thyroid hormone and adrenal replacement hormones for at
             least 14 days before Screen 1.

          5. Voluntarily given written informed consent to participate in this study.

        Exclusion Criteria:

          1. Received oral topical, intranasal, or buccal T therapy within the previous 2 weeks,
             intramuscular T injection of short-acting duration within the previous 4 weeks,
             intramuscular T injection of long-acting duration within the previous 20 weeks, or T
             implantable pellets within the previous 6 months.

          2. Received oral TU in a previous Clarus-sponsored investigational study.

          3. Significant intercurrent disease of any type; in particular, liver, kidney,
             uncontrolled or poorly controlled heart disease, including hypertension, congestive
             heart failure or coronary heart disease, or psychiatric-illness, including severe
             depression.

          4. Recent (within 2 years) history of stroke, transient ischemic attack, or acute
             coronary event.

          5. A mean of the triplicate assessment of systolic blood pressure (sBP) > 150 mm Hg
             and/or diastolic blood pressure (dBP) > 90 mm Hg at screening.

          6. Recent (within 2 years) history of angina or stent (coronary or carotid) placement.

          7. Untreated, severe obstructive sleep apnea.

          8. Clinically significant abnormal laboratory values (serum transaminases > 2 × ULN,
             serum bilirubin > 1.5 × ULN and serum creatinine > 1.5 × ULN).

          9. Hematocrit (HCT) value of < 35% or > 48%.

         10. Has a history of polycythemia, either idiopathic or associated with testosterone
             replacement therapy (TRT).

         11. Glycosylated hemoglobin (A1C) > 8.5%.

         12. BMI ≥ 38 kg/m2.

         13. If receiving the following medications:

               -  Has been on stable doses of lipid-lowering medication for < 3 months;

               -  Has been on stable doses of oral medication for diabetes for < 2 months; or

               -  Has been on stable doses of antihypertensive medication for < 3 months.

         14. Abnormal prostate digital rectal examination (palpable nodules), elevated Prostate
             Specific Antigen (serum PSA > 4.0 ng/mL), International Prostate Symptom Score (I-PSS)
             > 19 points at screening, and/or history of, or current or suspected, prostate cancer.

         15. History of, or current or suspected, breast cancer.

         16. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture
             or intravenous cannulation within the previous 2 years.

         17. Use of dietary supplements such as saw palmetto or phytoestrogens and any dietary
             supplements that may increase total T, such as androstenedione or
             dehydroepiandrosterone within the previous 4 weeks.

         18. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors and
             bile acid-binding resins.

         19. Inability to refrain from smoking during the confinement periods as required by the
             individual study center.

         20. History of alcohol abuse or any drug substance within the previous 2 years.

         21. Poor compliance or unlikely to keep clinic appointments.

         22. Has received any drug as part of another research study within 30 days of initial dose
             administration in this study.

         23. Donated blood (≥ 500 mL) within the 12-week period before the initial study dose.

         24. Currently uses antiandrogens, 5-alpha-reductase inhibitors, estrogens, potent oral
             CYP3A4 inducers, potent CYP3A4 inhibitors, or long acting opioid analgesics.

         25. Unwilling or unable to follow the dietary guidelines for this study, related to taking
             oral TU with meals that contain approximately 20 to 40 g of fat
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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