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

September 18, 2017 updated by: FBM Industria Brasileira Ltda

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nasotestt 5 mg
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.
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.
Other Names:
  • Test Group
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.
Other Names:
  • Placebo Comparator Group
Active Comparator: Androgel 50 mg
Participants randomized to this arm must administer one packet of Androgel 50 mg applied once daily to skin of shoulder 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 Names:
  • Active Comparator Group
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 Names:
  • Placebo Test Group
Placebo Comparator: Androgel Placebo
Participants must administer one packet of Androgel placebo applied once daily to skin of shoulder in addition to an experimental drug for 60 days.
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.
Other Names:
  • Test Group
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.
Other Names:
  • Placebo Comparator Group
Placebo Comparator: Nasotestt Placebo
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.
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 Names:
  • Active Comparator Group
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 Names:
  • Placebo Test Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels
Time Frame: 60 days
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.
60 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement of erectile dysfunction symptoms
Time Frame: 60 and 90 days after starting treatment.
Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.
60 and 90 days after starting treatment.
Improvement of prostatic symptoms
Time Frame: 60 and 90 days after starting treatment.
Will be evaluated by statistical comparison between I-PSS baseline values and results observed throughout study.
60 and 90 days after starting treatment.
Improvement of abdominal perimeter
Time Frame: 60 and 90 days after starting treatment.
Will be evaluated by statistical comparison between baseline perimeter observed and other results obtained throughout study.
60 and 90 days after starting treatment.
Global Clinical Response to treatment
Time Frame: 90 days after starting 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.
90 days after starting treatment.
Incidence of adverse events
Time Frame: During 120 days
Will be evaluated by periodic monitoring of adverse events, including changes in clinical laboratory parameters and vital signs occurred throughout the study.
During 120 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction and comfort of Nasotestt use
Time Frame: After 120 days
Will be evaluated by specific questionnaire application at the end of study.
After 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FBM Industria Brasileira Ltda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azidus Brasil Scientific Research and Development Ltda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alessandro Silva, Director, FBM Indústria Farmacêutica Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TESFBM0717NA-III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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