Clinical trial NCT03281187: Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.
Official title: A Randomized, Parallel, Double-dummy, Multi-center Phase III Study for Evaluation of Efficacy and Safety of Nasotestt Compared to Androgel Treating Hypogonadism in Male Research Participants.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypogonadism
Keywords: Hormonal reposition, Testosterone nasal, Nasotestt
Lead sponsor: FBM Industria Brasileira Ltda
Sponsor class: INDUSTRY
Collaborators: name: Azidus Brasil Scientific Research and Development Ltda
First posted: 2017-09-13
Enrollment: 228
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 clinical indication of hormonal replacement with testosterone.

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 through the percentage of participants which presented at the end of 60 days normalized levels of total testosterone (\<300 ng/dL to \>1050 ng/dL). Secondary efficacy endpoints will be collected throughout the study through: evaluation of symptoms of erectile dysfunction (The International Index of Erectile Function - IIEF), symptoms of prostatic disease (International Prostate Symptom Score - IPSS), measurement of abdominal perimeter and clinical global response to treatment (CGI-I questionnaire). As exploratory investigation, the satisfaction/comfort of Nasotestt use will be assessed by a specific questionnaire that will be applied to participants at the end of study. Safety evaluation data will include report of all adverse events, including type, frequency, intensity, seriousness, severity and action taken related to the investigational product of the study.

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.

Primary outcomes:
measure: Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels
timeFrame: 60 days
Secondary outcomes:
measure: Improvement of erectile dysfunction symptoms
timeFrame: 60 and 90 days after starting treatment.
measure: Improvement of prostatic symptoms
timeFrame: 60 and 90 days after starting treatment.
measure: Improvement of abdominal perimeter
timeFrame: 60 and 90 days after starting treatment.
measure: Global Clinical Response to treatment
timeFrame: 90 days after starting treatment.
measure: Incidence of adverse events
timeFrame: During 120 days
Other outcomes:
measure: Satisfaction and comfort of Nasotestt use
timeFrame: After 120 days
Locations:
Study officials:
affiliation: FBM Indústria Farmacêutica Ltda.
name: Alessandro Silva, Director
role: STUDY_DIRECTOR
References: