Clinical trial: Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) (NCT01919294)

Eligibility criteria:
Inclusion Criteria:

          -  Abnormal serum ALT on >2 occasions over at least 3 months, despite standard lifestyle
             advice when appropriate, in regard to moderation of alcohol intake, weight reduction
             and exercise.

          -  Negative serological tests for hepatitis Bs ag and C antibody.

          -  Alcohol consumption >21 units per week for no more than 2 week in the last year and
             for no more than 3 months of the past 5 years, assessed using a lifetime alcohol
             consumption questionnaire.

          -  Liver biopsy, performed as part of clinical management within 6 months of recruitment,
             which shows all of: (a) steatosis (Kleiner grade 2 or 3); (b) NASH (combined
             intralobular inflammation and hepatocyte ballooning score of >1); (c) fibrosis Ishak
             stage <4; and (d) no evidence to suggest another major liver disease.

          -  Hypotestosteronaemia, defined by total serum testosterone <11 nmol/L . Investigators
             predict that this will include about 25% of men with NAFLD as defined above.

        Exclusion Criteria:

          -  Inability to give informed consent.

          -  Age <18 or >75 years.

          -  Symptomatic sexual dysfunction.

          -  Cirrhosis either on baseline liver biopsy (Ishak score 5-6) or suggested by presence
             of varices, by ultrasound (small shrunken liver, ascites, splenomegaly) or by liver
             decompensation (encephalopathy, abnormal serum direct bilirubin, albumin or
             prothrombin time).

          -  Space occupying lesion on ultrasound with any suspicion of malignancy.

          -  Evidence of other chronic liver diseases pace occupying lesion on ultrasound with any
             suspicion of malignancy.

          -  Prostatic nodule or mass on PR examination unless full urological examination rules
             our prostate cancer

          -  Serum PSA or alpha feta protein above the age-specific normal range

          -  Carcinoma of male breast

          -  Taking medications (amiodarone, anti-retrovirals, sodium alproate, corticosteroids,
             tamoxifen) the previous 3 months (known to improve steatosis).

          -  Diabetes or hyperlipidaemia, where therapy has been changed within the last 12 months
             or with suboptimal control anticipating the need for change in therapy during the
             study.

          -  Severe or complicated obesity, likely requiring bariatric surgery in next 2 years.

          -  LH/FSH levels, raising the possibility of primary pituitary disease.

          -  Subject trying to or hoping to conceive within next 18 months.

          -  Haematocrit of >0.54

          -  History of any of the following: Sleep apnoea, breast or prostate or liver cancer,
             congestive heart failure, chronic renal failure (serum creatinine >150), severe
             chronic obstructive airways disease, uncontrolled hypertension epilepsy depression or
             migraine.

          -  Severe co morbidity likely in the opinion of the investigators to reduce life
             expectancy to <10 years.

          -  Hypersensitivity to active agent or to any of the excipients.

          -  On long-term warfarin or heparin-based anticoagulant therapy. Treatment with
             antiplatelet agents will not be an exclusion criterion, however, these will be omitted
             at the time of liver biopsies, as per normal clinical practice.
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? Contradiction