Clinical trial: Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043) (NCT03019575)

Eligibility criteria:
Inclusion Criteria:

          -  Have legal representative who understands the study procedures, alternative treatments
             available and risks involved with the study, and voluntarily agrees to the
             individual's participation by giving written informed consent, and the individual has
             an age-appropriate understanding of the same to give informed written assent if
             applicable.

          -  Diagnosed with hypogonadotropic hypogonadism (either isolated or associated with
             panhypopituitarism), either congenital or acquired with onset prior to puberty.

          -  Have bilateral pre-gonadarche testes as defined by testicular volume <4.0 mL for each
             testicle, as determined by ultrasound and assessed by the investigator (if qualified)
             or local radiologist with appropriate training and expertise in reading testicular
             ultrasound. Note: participants with a volume of <4.0 mL in one testicle and a volume
             of 4-8 mL in the other testicle are considered to be pre-gonadarche and may
             participate, if there is no history or evidence of a primary testicular disorder (see
             Exclusion Criteria 1 and 2).

          -  Have circulating levels of total testosterone (Total T) less than the lower limit of
             normal (LLN) of 8.3 nmol/L as specified by the central lab for a young healthy adult
             male.

          -  Have follicle stimulating hormone (FSH) ≤2 IU/L and luteinizing hormone (LH) ≤2 IU/L.

          -  Have inhibin-B levels ≤35 pg/mL. (Note: if individual has inhibin-B levels >35 pg/mL,
             but meets all of the other inclusion/exclusion criteria, either a GnRH agonist (GnRHa)
             stimulation test or GnRH IV infusion test may be performed.

          -  In good general physical and mental health, in the opinion of the
             investigator/sponsor, as assessed by physical examination and routine clinical
             laboratory tests.

          -  Have a parent/guardian able and willing to support the individual's participation by
             supporting adherence to study drug dosing and visit schedules.

        Exclusion Criteria:

          -  Have a history of bilateral cryptorchidism (maldescended testes) or unilateral
             cryptorchidism treated after the age of 2 years.

          -  Have a history or presence of clinically significant testicular problems (e.g.,
             epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy,
             occlusive azoospermia, etc.) that would impair participants response to treatment or
             has had known damage or injury to the vas deferens.

          -  Had any previous treatment with GnRH, gonadotropins (e.g., hCG, FSH) or androgens
             (e.g., testosterone, etc.). Note: Use of GnRH and gonadotropins for diagnostic testing
             purposes only is allowed. Participants with use of hCG and androgen therapy prior to
             the age of 2 years old can be included in the trial. Participants with transient use
             of androgens (i.e., for less than 2 weeks) that was stopped at least 6 months prior to
             signing informed consent can also be included in the trial.

          -  Has an untreated or inadequately treated pituitary or hypothalamic tumor.

          -  Have uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary
             disorders not on stable replacement therapies.

          -  Has a history of active pituitary hypersecretion as evidenced by hyperprolactinemia or
             Cushing's disease, acromegaly, or any other active pituitary hypersecretion syndrome.
             (Note: Individuals who have been treated and are clinically stable, with no evidence
             of hypersecretion for at least 12 months prior to screening, may participate.

          -  Has had hypophysectomy within 12 months to the start of screening.

          -  Has history of oncologic chemotherapy treatment.

          -  Has had brain radiotherapy within 12 months of start of treatment for a primary tumor,
             or any history of brain radiotherapy for metastatic disease.

          -  Has diabetes mellitus.

          -  Has history of Human Immunodeficiency Virus (HIV).

          -  Has renal insufficiency, as determined by investigator, based on serum creatinine,
             blood urea nitrogen, and estimated glomerular filtration rate.

          -  Has clinically significant liver disease, including active viral hepatitis or
             cirrhosis. Individuals with a prior history of liver disease which is now inactive or
             successfully treated may be enrolled if all liver function values performed within the
             past year have been normal and within the normal range at Visit 1.

          -  Has had a recent history of recreational or illicit drug use, including marijuana; or
             routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or
             engages in binge drinking.

          -  Has an allergy/sensitivity to gonadotropins or its/their excipients.

          -  Has used an investigational drug and/or participated in any other clinical trial
             within the past 8 weeks (prior to Visit 2), or will participate in any other clinical
             trials (excluding surveys) during the course of this trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 17 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