Clinical trial: Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (NCT04798469)

Eligibility criteria:
Inclusion Criteria:

          -  Men, age 18 years and older.

          -  Chronic non-cancer back pain.

          -  Use of opioid analgesics for at least 6 months.

          -  Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free
             testosterone <70 pg/mL.

          -  Ability and willingness to provide informed consent.

        Exclusion Criteria:

          -  History of prostate cancer or breast cancer.

          -  Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or
             testicular disease).

          -  Use of testosterone within the past 6 months.

          -  Baseline hematocrit >48%.

          -  Prostate-specific antigen (PSA) level >4 ng/mL in Caucasians or >3 ng/mL in
             African-Americans.

          -  Presence of prostate nodule or induration on digital rectal examination.

          -  Uncontrolled congestive heart failure.

          -  Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke
             within 3 months.

          -  Serum creatinine >2.5 mg/dL.

          -  Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.

          -  Diagnosis of bipolar disorder or schizophrenia.

          -  Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the
             patient from undergoing functional magnetic resonance imaging (MRI). In subjects who
             are otherwise eligible and either do not qualify for MRI or are reluctant to undergo
             imaging, the investigators may consider enrolling such participants on a case-by-case
             basis.
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? Contradiction