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

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ClinicalTrials.gov Identifier: NCT03281187
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Azidus Brasil Scientific Research and Development Ltda
Information provided by (Responsible Party):
FBM Industria Brasileira Ltda

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Nasotestt 5 mg Drug: Androgel 50 mg Other: Nasotestt Placebo Other: Androgel Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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).
Primary Purpose: Treatment
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.
Estimated Study Start Date : July 16, 2018
Estimated Primary Completion Date : November 12, 2018
Estimated Study Completion Date : January 13, 2020


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Placebo Test Group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. Satisfaction and comfort of Nasotestt use [ Time Frame: After 120 days ]
    Will be evaluated by specific questionnaire application at the end of study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281187


Contacts
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Contact: Maxuel Monteiro, Regulatory +55(62)3333-3500 ext 3612 maxuel.monteiro@fbmfarma.com.br
Contact: Luciana Ferrara, CRO +55(19)3829-6160 luciana.ferrara@azidusbrasil.com.br

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

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Responsible Party: FBM Industria Brasileira Ltda
ClinicalTrials.gov Identifier: NCT03281187     History of Changes
Other Study ID Numbers: TESFBM0717NA-III
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data wil become public.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by FBM Industria Brasileira Ltda:
Hormonal reposition, Testosterone nasal, Nasotestt

Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents