Clinical trial: Autonomic Manifestations of Testosterone Deficiency in Men (NCT02715713)

Eligibility criteria:
Inclusion Criteria for first group:

          1. Patients with testosterone deficiency (total testosterone< 277 ng/dL [9.6 nmol/L])
             measured between 7-10 am, and with one or more symptoms and signs suggestive of
             androgen deficiency as mainly determined by history.

               -  Reduced sexual desire (libido)

               -  Decreased spontaneous erections

               -  Breast discomfort, gynecomastia

               -  Loss of body (axillary and pubic) hair - reduced shaving

               -  Very small (<5ml) or shrinking testes

               -  Height loss

               -  Low trauma fracture

               -  Low bone mineral density

               -  Hot flushes

               -  Sweats

               -  Decreased energy

               -  Decreased motivation

               -  Decreased initiative

               -  Decreased self confidence

               -  Feeling sad or blue

               -  Depressed mood

               -  Dysthymia

               -  Poor concentration

               -  Poor memory

               -  Sleep disturbance

               -  Increased sleepiness

          2. Age 40 to 80 years

        Inclusion Criteria for second group:

          1. Patients who underwent chemical or surgical castration for prostatic cancer who are
             going to receive androgen deprivation therapy.

          2. Age 40 to 80 years

        Exclusion Criteria (both groups):

        1. Patients with history or current diagnosis of:

          -  Atrial fibrillation.

          -  Cardiac arrythmia

          -  Pacemaker placement.

          -  Myocardial infarction < 3 months

          -  Uncontrolled diabetes mellitus with hemoglobin A1c > 8.5% in the last 6 months.

          -  Diabetes mellitus with autonomic neuropathy

          -  Breast cancer

          -  Heart failure with left ventricular ejection fraction below 35%.

          -  Severe sleep apnea.

          -  Recent eye surgery (< 3 months)

          -  Recent ischemic stroke (< 3 months)

          -  History of retinal detachment.

          -  History of brain aneurysm.

          -  Severe chronic obstructive pulmonary disease (COPD) on oxygen therapy.

          -  Intraocular hemorrhage and lens dislocation.

          -  Glaucoma.

          -  Thyroid disease.

          -  Not literate in English

        Exclusion Criteria for patient who will receive testosterone treatment

          -  Metastatic prostate cancer

          -  Prostate-specific antigen (PSA) concentration >4.0 mcg/L,

          -  Prostate-specific antigen (PSA) >3.0 mcg/L in high-risk men (African-Americans or men
             with first-degree relatives with prostate cancer). (Measured at clinic visit 1)

          -  Polycythemia (hemoglobin level >18 g/dL, hematocrit > 52%) (measured at clinic visit
             1)

          -  Severe acne.

          -  History of venous or arterial thrombosis.

          -  Persons not literate in English
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 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