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

NCT ID: NCT03281187

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-01-13

Brief Summary

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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

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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.

Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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).

Study Groups

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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.

Group Type EXPERIMENTAL

Nasotestt 5 mg

Intervention Type DRUG

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.

Androgel Placebo

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Androgel 50 mg

Intervention Type DRUG

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.

Nasotestt Placebo

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Nasotestt 5 mg

Intervention Type DRUG

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.

Androgel Placebo

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Androgel 50 mg

Intervention Type DRUG

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.

Nasotestt Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Test Group Active Comparator Group Placebo Test Group Placebo Comparator Group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Azidus Brasil Scientific Research and Development Ltda

OTHER

Sponsor Role collaborator

FBM Industria Brasileira Ltda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro Silva, Director

Role: STUDY_DIRECTOR

FBM Indústria Farmacêutica Ltda.

Central Contacts

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Maxuel Monteiro, Regulatory

Role: CONTACT

[email protected]
+55(62)3333-3500 ext. 3612

Luciana Ferrara, CRO

Role: CONTACT

[email protected]
+55(19)3829-6160

Other Identifiers

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TESFBM0717NA-III

Identifier Type: -

Identifier Source: org_study_id