Status:
UNKNOWN
Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.
Lead Sponsor:
FBM Industria Brasileira Ltda
Collaborating Sponsors:
Azidus Brasil Scientific Research and Development Ltda
Conditions:
Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 clinica...
Detailed Description
This efficacy and safety study will evaluate the superiority of Nasotestt (nasal gel) treatment compared to Androgel (topic gel) after 60 days of starting use. The efficacy endpoint will be verified t...
Eligibility Criteria
Inclusion
- Male research participant, aged 18 years or older, with BMI between 18.50 and 32.00 kg/m2;
- To present symptomatic or asymptomatic hypogonadism and serum total morning testosterone levels ≤ 300 ng / dL;
- 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;
- Rhinoscopy and Glatzel mirror test normal or with changes that do not interfere with nasal absorption of medication Test;
- Present healthy skin in the region of Comparator product application (skin of the shoulder).
Exclusion
- Diagnostic of prostatic and/or breast neoplasia;
- PSA levels 4 ng/mL or higher, or 3 ng/mL or higher with elevated risk for prostatic neoplasia development;
- Treatment with estrogens, gonadotropin releasing hormone (GnRH), growth hormone (GH) in the last 12 months;
- 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;
- Active rhinitis: allergic, seasonal, medicinal, vasomotor and atrophic;
- 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;
- Hypersensibility of testosterone as well as to components present in the formulation of drugs.
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 13 2020
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03281187
Start Date
July 16 2018
End Date
January 13 2020
Last Update
September 19 2017
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