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

• Status: Unknown status
• Trial end date: 2020-01-13
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase III study for evaluation of Nasotestt efficacy compared to Androgel in the treatment of male participants with hypogonadism condition (reduced levels of testosterone) that have clinical indication of hormonal replacement with testosterone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FBM Industria Brasileira Ltda
• Collaborators: Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda; Azidus Brasil Scientific Research and Development Ltda
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.