HypogonadismPhase 3NCT03281187
Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.
A Phase 3 study testing Nasotestt 5 mg and Androgel 50 mg in people with Hypogonadism, run by FBM Industria Brasileira Ltda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Nasotestt 5 mg and Androgel 50 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2018to 13 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Hypogonadism
- Being tested
- Nasotestt 5 mg, Androgel 50 mg, Nasotestt Placebo, Androgel Placebo
- Keywords
- Hormonal reposition, Testosterone nasal, Nasotestt
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasotestt 5 mgDrug
Also called Test Group
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 50 mgDrug
Also called Active Comparator Group
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 PlaceboOther
Also called Placebo Test Group
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 PlaceboOther
Also called Placebo Comparator Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasotestt 5 mg | Experimental | 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. Receives: Drug: Nasotestt 5 mg; Other: Androgel Placebo |
| Androgel 50 mg | Active comparator | Participants randomized to this arm must administer one packet of Androgel 50 mg applied once daily to skin of shoulder for 60 days. Receives: Drug: Androgel 50 mg; Other: Nasotestt Placebo |
| Androgel Placebo | Placebo comparator | Participants must administer one packet of Androgel placebo applied once daily to skin of shoulder in addition to an experimental drug for 60 days. Receives: Drug: Nasotestt 5 mg; Other: Androgel Placebo |
| Nasotestt Placebo | Placebo comparator | 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. Receives: Drug: Androgel 50 mg; Other: Nasotestt Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (5)
Improvement of erectile dysfunction symptoms
Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start16 Jul 2018 (estimated)
- Primary completion12 Nov 2018 (estimated)
- Study completion13 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FBM Industria Brasileira Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil Scientific Research and Development Ltda
- Responsible party
- Sponsor
- Investigators
- Alessandro Silva, Director, Study director, FBM Indústria Farmacêutica Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281187
- Sponsor's protocol ID
- TESFBM0717NA-III
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data wil become public.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03281187
- Acronym / sponsor ID
- TESFBM0717NA-III
- Conditions
- Hypogonadism
- Keywords
- Hormonal reposition, Testosterone nasal, Nasotestt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- FBM Industria Brasileira LtdaIndustry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil Scientific Research and Development Ltda
- Study start
- 16 Jul 2018 (estimated)
- Primary completion
- 12 Nov 2018 (estimated)
- Study completion
- 13 Jan 2020 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nasotestt 5 mg | Experimental | Drug: Nasotestt 5 mg, Other: Androgel PlaceboParticipants 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. |
| Androgel 50 mg | Active comparator | Drug: Androgel 50 mg, Other: Nasotestt PlaceboParticipants randomized to this arm must administer one packet of Androgel 50 mg applied once daily to skin of shoulder for 60 days. |
| Androgel Placebo | Placebo comparator | Drug: Nasotestt 5 mg, Other: Androgel PlaceboParticipants must administer one packet of Androgel placebo applied once daily to skin of shoulder in addition to an experimental drug for 60 days. |
| Nasotestt Placebo | Placebo comparator | Drug: Androgel 50 mg, Other: Nasotestt PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasotestt 5 mgAlso: Test GroupThe 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. | Drug | Androgel Placebo, Nasotestt 5 mg |
| Androgel 50 mgAlso: Active Comparator GroupThe 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. | Drug | Androgel 50 mg, Nasotestt Placebo |
| Nasotestt PlaceboAlso: Placebo Test GroupThe 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 | Androgel 50 mg, Nasotestt Placebo |
| Androgel PlaceboAlso: Placebo Comparator GroupThe 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 | Androgel Placebo, Nasotestt 5 mg |
Primary outcome
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.
5 secondary outcomes
Improvement of erectile dysfunction symptoms
Time frame: 60 and 90 days after starting treatment.
Improvement of prostatic symptoms
Time frame: 60 and 90 days after starting treatment.
Improvement of abdominal perimeter
Time frame: 60 and 90 days after starting treatment.
Global Clinical Response to treatment
Time frame: 90 days after starting treatment.
Incidence of adverse events
Time frame: During 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Silva, Director study director
FBM Indústria Farmacêutica Ltda.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nasotestt 5 mg and Androgel 50 mg in people with Hypogonadism, run by FBM Industria Brasileira Ltda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxuel Monteiro, Regulatory (+55(62)3333-3500 ext. 3612, maxuel.monteiro@fbmfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority Efficacy of Nasotestt comparing to Androgel on normalization of the blood testosterone levels (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.