Clinical trial: Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot) (NCT02959853)

Eligibility criteria:
Inclusion Criteria:

          -  severely obese (BMI >= 35) male veterans with hypogonadotropic hypogonadism defined as
             low total testosterone (lower than 300 ng/dl) between 35-65 years of age

          -  Luteinizing hormone (LH) lower than 9 U/L

          -  estradiol above 40 pmol/l

          -  normal Free T4 (FT4), Thyroid Stimulating Hormone (TSH), prolactin, cortisol,
             Adrenocorticotropic hormone (ACTH), and Insulin-like growth factor-1 (IGF-1) levels.

          -  Subjects must be ambulatory, willing and able to provide written informed consent

        Exclusion Criteria:

          -  clinical or biochemical evidence of pituitary or hypothalamic disease

          -  any ongoing illness that, in the opinion of the investigator, could prevent the
             subject from completing study

          -  any med known to affect gonadal hormones, steroid hormone-binding globulin or bone
             metabolism, e.g.,

               -  androgens

               -  estrogens

               -  glucocorticoids

               -  phenytoin

               -  bisphosphonates

               -  any medication known to interfere with anastrozole metabolism, e.g. tamoxifen or
                  estrogens

          -  diseases known to interfere with bone metabolism as

               -  osteoporosis

               -  hyperparathyroidism

               -  untreated hyperthyroidism

               -  osteomalacia

               -  chronic liver disease

               -  renal failure

               -  hypercortisolism

               -  malabsorption

               -  immobilization

               -  patients with a Total T score lower than -2.0 at Lumbar Spine or Left Femur.

          -  patients with symptomatic prostate disease, prostate carcinoma, or elevated serum
             Prostate-specific antigen (PSA) >4 ng/ml or >3 for subjects with a family history of
             prostate cancer among 1st degree relatives needs urologic evaluation before admission
             into study

          -  hematocrit greater than 50%

          -  untreated severe obstructive sleep apnea

          -  severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS)
             above 19

          -  documented heart failure

          -  cardiovascular disease

          -  liver disease

          -  excessive alcohol or substance abuse

          -  unstable weight (changes in weight more than ± 2 kg) during the last 3 months

          -  history of bariatric surgery

          -  subjects with elevated liver enzymes as alanine transaminase (ALT), aspartate
             aminotransferase (AST), Alkaline phosphatase (ALP), and bilirubin at greater than
             twice the upper limit of normal.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 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? Contradiction