Clinical trial: Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men. (NCT03281187)

Eligibility criteria:
Inclusion Criteria:

          1. Male research participant, aged 18 years or older, with BMI between 18.50 and 32.00
             kg/m2;

          2. To present symptomatic or asymptomatic hypogonadism and serum total morning
             testosterone levels ≤ 300 ng / dL;

          3. Laboratory evaluation of prostate specific antigen (PSA) levels within the normal
             range established by the laboratory or with non clinically significant changes (NCS)
             judged by the study Investigator;

          4. Rhinoscopy and Glatzel mirror test normal or with changes that do not interfere with
             nasal absorption of medication Test;

          5. Present healthy skin in the region of Comparator product application (skin of the
             shoulder).

        Exclusion Criteria:

          1. Diagnostic of prostatic and/or breast neoplasia;

          2. PSA levels 4 ng/mL or higher, or 3 ng/mL or higher with elevated risk for prostatic
             neoplasia development;

          3. Treatment with estrogens, gonadotropin releasing hormone (GnRH), growth hormone (GH)
             in the last 12 months;

          4. Treatment with testosterone or any other androgen in the last two weeks (oral, buccal
             and topic), four weeks (intramuscular) or twelve weeks (implant) that precede
             randomization in the study;

          5. Active rhinitis: allergic, seasonal, medicinal, vasomotor and atrophic;

          6. Presence of grade II or III septum deviation (in any region of the nasal septum) and /
             or presence of nasal polyps or other conditions that determine nasal obstruction;

          7. Hypersensibility of testosterone as well as to components present in the formulation
             of drugs.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Entailment