Clinical trial: A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937) (NCT01709331)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosed with hypogonadotropic hypogonadism, either congenital or acquired

          -  Have low circulating levels of testosterone

          -  Have low circulating levels of gonadotropins (follicle stimulating hormone [FSH];
             luteinizing hormone)

          -  Presence of both scrotal testes

          -  Have azoospermia (no measurable level of sperm)

          -  Adequate replacement of other pituitary hormones

          -  Good general physical and mental health

        Exclusion Criteria:

          -  Primary hypogonadism, such as Klinefelter's syndrome

          -  History of unilateral or bilateral cryptorchidism (maldescended testes)

          -  History or presence of testicular pathology of clinical importance (e.g.,
             epididymitis, orchitis, testicular torsion, varicocele stage III, testicular atrophy,
             occlusive azoospermia, etc), and/or vasectomy

          -  Treated with FSH, hCG or gonadotropin-releasing hormone (GnRH) within previous 3
             months or for more than 1 month within previous 6 months

          -  Proven spermatogenesis with hCG treatment alone

          -  Previous unsuccessful attempt with hCG in combination with human menopausal
             gonadotropin (hMG)/FSH to achieve spermatogenesis

          -  Required a dose of hCG of more than 6000 international units (IU) per week in a
             previous attempt to normalize T levels

          -  Untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or
             hypothalamic tumor that is likely to progress during the study

          -  History or presence (known or suspected) of testicular, prostatic or breast cancer

          -  Prostate pathology of clinical importance

          -  Past or present oncologic treatment (chemo/radiotherapy)

          -  Diabetes mellitus

          -  Clinically significant, untreated hyperprolactinaemia

          -  Uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)

          -  Tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C

          -  User of recreational or illicit drugs or has had a recent history (within the past
             year) of drug abuse or dependence, or increased alcohol consumption

          -  Allergy/sensitivity to gonadotropins or its/their excipients

          -  Has received within previous 1 month or plans to use: Hormonal preparations other than
             the study medication, drugs that are known to impair testicular function, agents known
             to affect sex hormone secretion and/or drugs that are known or suspected to be
             teratogenic

          -  Used any investigational drugs within three months or actively participating in
             another study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 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