Clinical trial: Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters (NCT03203681)

Eligibility criteria:
Inclusion Criteria:

          -  Voluntarily sign and date the study consent form(s) which have been approved by an
             Institutional Review Board (IRB). Written consent must be obtained prior to the
             initiation of any study procedures.

          -  Male between 18 and 55 years of age, inclusive, with documented onset of hypogonadism
             prior to age 55.

          -  Documented diagnosis of primary hypogonadism (congenital or acquired) or
             hypogonadotropic hypogonadism (congenital or acquired).

          -  Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained at
             least 1.5 hours apart between 6:00 am and 10:00 am following an appropriate washout of
             current androgen replacement therapy.

          -  Naïve to androgen replacement or has discontinued current treatment and completed a
             washout of 4 weeks following androgen treatment (excluding Testopel). Washout must be
             completed prior to collection of baseline serum testosterone samples to determine
             study eligibility.

          -  Judged to be in good general health as determined by the principal investigator based
             upon the results of a medical history, physical examination, vital signs, laboratory
             profile and a 12-lead electrocardiogram (ECG).

        Exclusion Criteria:

          -  History of significant sensitivity or allergy to androgens, castor oil or product
             excipients.

          -  Clinically significant findings in the prestudy examinations including abnormal breast
             examination requiring follow-up, abnormal ECG.

          -  Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or
             International Prostate Symptoms Score (I-PSS) > 19 points.

          -  Body mass index (BMI) ≥ 30 kg/m2.

          -  Clinically significant abnormal laboratory value, in the opinion of the investigator,
             in serum chemistry, hematology, or urinalysis including but not limited to:

               1. Baseline hemoglobin < 11.5 g/dL or > 16 g/dL

               2. Hematocrit < 35% or > 54%

               3. Serum transaminases > 2.5 times upper limit of normal

               4. Serum bilirubin > 2.0 mg/dL

               5. Creatinine > 2.0 mg/dL f. Prostate-Specific Antigen (PSA) > 2 ng/mL

          -  History of seizures or convulsions, including febrile, alcohol or drug withdrawal
             seizures.

          -  History of any clinically significant illness, infection, or surgical procedure within
             4 weeks prior to study drug administration.

          -  History of stroke or myocardial infarction within the past 5 years.

          -  History of, or current or suspected, prostate or breast cancer.

          -  History of diagnosed, severe, untreated, obstructive sleep apnea.

          -  History of abuse of alcohol or any drug substance in the opinion of the investigator
             within the previous 2 years.

          -  Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt
             of a transfusion of any blood product within 12 weeks prior to the start of treatment.

          -  Inadequate venous access for collection of serial blood samples required for
             pharmacokinetic profiles.

          -  Receipt of any investigational product within 4 weeks or within 5 half-lives prior to
             the start of treatment.

          -  Inability to understand and provide written informed consent for the study.

          -  Considered by the investigator or the sponsor-designated physician, for any reason,
             that the subject is an unsuitable candidate to receive Natesto.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 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? 1