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

Primary Purpose

Hypogonadism

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Nasotestt 5 mg

Androgel 50 mg

Nasotestt Placebo

Androgel Placebo

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Hormonal reposition, Testosterone nasal, Nasotestt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Nasotestt 5 mg

Androgel 50 mg

Androgel Placebo

Nasotestt Placebo

Arm 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.

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

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

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.

Outcomes

Primary Outcome Measures

Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels

The success of treatment will be evaluated through statistical comparison of percentage of participants that achieved normal blood testosterone levels after 60 days of use.

Secondary Outcome Measures

Improvement of erectile dysfunction symptoms

Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.

Improvement of prostatic symptoms

Will be evaluated by statistical comparison between I-PSS baseline values and results observed throughout study.

Improvement of abdominal perimeter

Will be evaluated by statistical comparison between baseline perimeter observed and other results obtained throughout study.

Global Clinical Response to treatment

Will be assessed by a CGI - I questionnaire applied at the end of study. This instrument evaluate the improvement observed by physician throughout the study compared to condition observed at the baseline visit.

Incidence of adverse events

Will be evaluated by periodic monitoring of adverse events, including changes in clinical laboratory parameters and vital signs occurred throughout the study.

Full Information

NCT ID

NCT03281187

First Posted

September 11, 2017

Last Updated

September 18, 2017

Sponsor

FBM Industria Brasileira Ltda

Collaborators

Azidus Brasil Scientific Research and Development Ltda

1. Study Identification

Unique Protocol Identification Number

NCT03281187

Brief Title

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

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 16, 2018 (Anticipated)

Primary Completion Date

November 12, 2018 (Anticipated)

Study Completion Date

January 13, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FBM Industria Brasileira Ltda

Collaborators

Azidus Brasil Scientific Research and Development Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

Hormonal reposition, Testosterone nasal, Nasotestt

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Due to the differences on test and comparator product a double-dummy design will be used retaining the blind of the study. Therefore each participant will receive an active product and inactive medication (placebo).

Allocation

Randomized

Enrollment

228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nasotestt 5 mg

Arm Type

Experimental

Arm 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.

Arm Title

Androgel 50 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Androgel Placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

Nasotestt Placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Nasotestt 5 mg

Other Intervention Name(s)

Test Group

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Androgel 50 mg

Other Intervention Name(s)

Active Comparator Group

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Nasotestt Placebo

Other Intervention Name(s)

Placebo Test Group

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Androgel Placebo

Other Intervention Name(s)

Placebo Comparator Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels

Description

The success of treatment will be evaluated through statistical comparison of percentage of participants that achieved normal blood testosterone levels after 60 days of use.

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Improvement of erectile dysfunction symptoms

Description

Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.

Time Frame

60 and 90 days after starting treatment.

Title

Improvement of prostatic symptoms

Description

Will be evaluated by statistical comparison between I-PSS baseline values and results observed throughout study.

Time Frame

60 and 90 days after starting treatment.

Title

Improvement of abdominal perimeter

Description

Will be evaluated by statistical comparison between baseline perimeter observed and other results obtained throughout study.

Time Frame

60 and 90 days after starting treatment.

Title

Global Clinical Response to treatment

Description

Time Frame

90 days after starting treatment.

Title

Incidence of adverse events

Description

Will be evaluated by periodic monitoring of adverse events, including changes in clinical laboratory parameters and vital signs occurred throughout the study.

Time Frame

During 120 days

Other Pre-specified Outcome Measures:

Title

Satisfaction and comfort of Nasotestt use

Description

Will be evaluated by specific questionnaire application at the end of study.

Time Frame

After 120 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maxuel Monteiro, Regulatory

Phone

+55(62)3333-3500

Ext

3612

maxuel.monteiro@fbmfarma.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Luciana Ferrara, CRO

Phone

+55(19)3829-6160

luciana.ferrara@azidusbrasil.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessandro Silva, Director

Organizational Affiliation

FBM Indústria Farmacêutica Ltda.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data wil become public.

Learn more about this trial

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

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