Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.

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.