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

NCT03281187 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2017-09-19

No results posted yet for this study

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.

Conditions

  • Hypogonadism

Interventions

DRUG

Nasotestt 5 mg

The 114 participants randomized to this arm must administer one packet of testosterone 5 mg nasal gel (Nasotestt) in each nostril 3 times a day for 60 days.

DRUG

Androgel 50 mg

The 114 participants randomized to this arm must administer one packet of testosterone 50 mg topic gel (Androgel) applied once daily to skin of shoulders for 60 days.

OTHER

Nasotestt Placebo

The participants randomized to this arm must administer one packet of placebo testosterone nasal gel (Nasotestt Placebo) in each nostril 3 times a day in addition to an active drug for 60 days.

OTHER

Androgel Placebo

The participants randomized to this arm must administer one packet of placebo testosterone topic gel (Androgel Placebo) applied once daily to skin of shoulders in addition to an active drug for 60 days.

Sponsors & Collaborators

  • Azidus Brasil Scientific Research and Development Ltda

    collaborator OTHER

  • FBM Industria Brasileira Ltda

    lead INDUSTRY

Principal Investigators

  • Alessandro Silva, Director · FBM Indústria Farmacêutica Ltda.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2018-11-12
Completion
2020-01-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03281187 on ClinicalTrials.gov