A Phase 3 interventional study of Nasotestt 5 mg and Androgel 50 mg in Hypogonadism, sponsored by FBM Industria Brasileira Ltda. Status unknown. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by FBM Industria Brasileira Ltda · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 · Other: Androgel Placebo
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 · Other: Nasotestt 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 · Other: Androgel 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 · Other: Nasotestt Placebo
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.
Also known as: Test 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.
Also known as: Active Comparator 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.
Also known as: Placebo Test 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.
Also known as: Placebo Comparator Group
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.
Time frame: 60 days
Improvement of erectile dysfunction symptoms
Will be evaluated by statistical comparison between IIEF baseline values and results observed throughout study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During 120 days
Satisfaction and comfort of Nasotestt use
Will be evaluated by specific questionnaire application at the end of study.
Time frame: After 120 days
No study locations are listed for this record.
Plan to share: Undecided — It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data wil become public.
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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