Clinical trial: An Open-label Dose Finding Study Followed by a Parallel Group, Randomized, Double-blind Study to Evaluate the Safety, Tolerability and Pharmacodynamics of 12 Week BGS649 Treatment in Obese, Hypogonadotropic Hypogonadal Men (NCT01200862)

Eligibility criteria:
Inclusion Criteria:

          -  Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:

               -  Patients with a Body Mass Index (BMI) ≥ 30 kg/m2

               -  Patients with a morning serum total testosterone level < 300 ng/dL on at least
                  two separate occasions during the Screening and/or Baseline periods.

               -  Patients with inappropriately low gonadotropins at screening given the low
                  testosterone:

          -  Luteinizing hormone (LH) ≤ ULN

          -  Follicle stimulating hormone (FSH) ≤ ULN

          -  Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)

               -  Normal hypothalamic/pituitary function, including:

          -  Prolactin: within the normal range

          -  Thyroid stimulating hormone (TSH): within the normal range

          -  Ferritin: within the normal range

          -  Patients agree to use a barrier method of contraception (e.g., condom), for the
             duration of the study and for at least 3 months following their Study Completion visit
             to prevent BGS649 exposure to their partners.

        Exclusion Criteria:

          -  Patients with hypogonadism, not related to obesity or as a result of other underlying
             issues

          -  Patients with significant major organ class illness (e.g. kidney or liver disease).

          -  Other protocol-defined inclusion/exclusion criteria may apply
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 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? 0