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

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: Unknown
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: Nasotestt 5 mg; Other: Androgel Placebo; Drug: Androgel 50 mg; Other: Nasotestt Placebo

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: Interventional
• Enrollment (Anticipated): 228
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of erectile dysfunction symptoms	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Satisfaction and comfort of Nasotestt use	Will be evaluated by specific questionnaire application at the end of study.	After 120 days

Collaborators and Investigators

• Sponsor: FBM Industria Brasileira Ltda
• Collaborators: Azidus Brasil Scientific Research and Development Ltda
• Investigators: Study Director: Alessandro Silva, Director, FBM Indústria Farmacêutica Ltda.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 16, 2018
• Primary Completion (Anticipated): November 12, 2018
• Study Completion (Anticipated): January 13, 2020

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Hormonal reposition, Testosterone nasal, Nasotestt
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID 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