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

FBM Industria Brasileira

Status and phase: Unknown; Phase 3

Conditions: Hypogonadism

Treatments: Other: Nasotestt Placebo; Other: Androgel Placebo; Drug: Nasotestt 5 mg; Drug: Androgel 50 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03281187

TESFBM0717NA-III

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 4 patient groups, including a placebo group

Nasotestt 5 mg

Experimental group

Description:

Participants randomized to this arm must administer one packet of Nasotestt 5 mg in each nostril (3 times a day - T.I.D) for 60 days.

Treatment:

Other: Androgel Placebo

Drug: Nasotestt 5 mg

Androgel 50 mg

Active Comparator group

Description:

Participants randomized to this arm must administer one packet of Androgel 50 mg applied once daily to skin of shoulder for 60 days.

Treatment:

Drug: Androgel 50 mg

Other: Nasotestt Placebo

Androgel Placebo

Placebo Comparator group

Description:

Participants must administer one packet of Androgel placebo applied once daily to skin of shoulder in addition to an experimental drug for 60 days.

Treatment:

Other: Androgel Placebo

Drug: Nasotestt 5 mg

Nasotestt Placebo

Placebo Comparator group

Description:

Participants must administer one packet of Nasotestt Placebo in each nostril (3 times a day - T.I.D) in addition to an experimental drug for 60 days.

Treatment:

Drug: Androgel 50 mg

Other: Nasotestt Placebo