Clinical trial: Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1% (NCT02667561)

Eligibility criteria:
Inclusion Criteria:

          -  Female subjects aged ≥ 42 years and ≤ 65 years, in post-menopausal period for at least
             1 year and with active sexual life;

          -  Serum testosterone levels < 33 ng/mL;

          -  Follicle-stimulating hormone (FSH) levels > 22 mU/mL;

          -  Absence of other significant diseases which, at the physician's discretion, could
             impact subject's participation in the trial, according to protocol requirements, and
             study evaluations: medical history, blood pressure and heart rate measurements,
             physical examination and complimentary laboratory tests;

          -  Ability to understand the nature and objective of the trial, including risks and
             adverse events, which shall be confirmed by Informed Consent Form signature.

        Exclusion Criteria:

          -  Screening laboratory tests results presenting clinically relevant deviations that, at
             the investigator discretion, prevent the subject to participate in the trial due to
             possible risks;

          -  Drugs addiction, including alcohol;

          -  Treatment with any drugs known to have a well-established toxic potential to major
             organs, within 3 months before the trial, ;

          -  Participation in any other experimental research or administration of any experimental
             drug within six months before the initiation of this trial;

          -  Pregnancy, labor or miscarriage in the last 12 weeks before the antecipated date of
             the study treatment start;

          -  Any conditions, according to investigator's best judgement, that prevents the subject
             to participate in the trial.
Female
Accepts Healthy Volunteers
Subject must be at least 42 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? Contradiction