Clinical trial: Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone (NCT02381288)

Eligibility criteria:
Inclusion Criteria:

          1. Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.

          2. Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.

          3. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from the time of signing
             of informed consent throughout the duration of the study and for 12 weeks after the
             last dose.

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality
             that may impact the ability of the participant to participate or potentially confound
             the study results. Participants will be excluded based on:

               1. Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.

               2. Is receiving dialysis treatment.

               3. Has an American Urological Association (AUA)/ International Prostate Symptom
                  Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram
                  per milliliter (ng/mL) at Screening.

               4. Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units
                  per liter (mIU/L) at Screening.

               5. Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood
                  pressure >100 mm Hg (if out of range may be repeated once for eligibility
                  determination) at Screening.

               6. Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.

               7. Is receiving insulin therapy.

               8. Has a hematocrit <30 percent (%) or >48% at Screening.

               9. Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).

          2. Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated
             hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).

          3. Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular
             disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome,
             systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or
             prior pituitary surgery.

          4. Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists,
             antiandrogens, clomiphene, or other reproductive hormone-related agents within 6
             months prior to Screening.

          5. Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA],
             androstendione, any other androgen, or recombinant human growth hormone) within 1 year
             of Screening.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 60 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? Contradiction