NCT03281187

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

September 11, 2017

Last Update Submit

September 18, 2017

Conditions

Hypogonadism

Keywords

Hormonal reposition, Testosterone nasal, Nasotestt

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Improvement of erectile dysfunction symptoms

    60 and 90 days after starting treatment.

  • Improvement of prostatic symptoms

    60 and 90 days after starting treatment.

  • Improvement of abdominal perimeter

    60 and 90 days after starting treatment.

  • Global Clinical Response to treatment

    90 days after starting treatment.

  • Incidence of adverse events

    During 120 days

Other Outcomes (1)

  • Satisfaction and comfort of Nasotestt use

    After 120 days

Study Arms (4)

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.

Drug: Nasotestt 5 mgOther: 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.

Drug: Androgel 50 mgOther: 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.

Drug: Nasotestt 5 mgOther: 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.

Drug: Androgel 50 mgOther: Nasotestt Placebo

Interventions

Nasotestt 5 mgDRUG

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
Androgel PlaceboNasotestt 5 mg
Androgel 50 mgDRUG

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
Androgel 50 mgNasotestt Placebo
Nasotestt PlaceboOTHER

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
Androgel 50 mgNasotestt Placebo
Androgel PlaceboOTHER

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
Androgel PlaceboNasotestt 5 mg

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Alessandro Silva, Director

    FBM Indústria Farmacêutica Ltda.

    STUDY DIRECTOR

Central Study Contacts

Maxuel Monteiro, Regulatory

CONTACT

+55(62)3333-3500maxuel.monteiro@fbmfarma.com.br

Luciana Ferrara, CRO

CONTACT

+55(19)3829-6160luciana.ferrara@azidusbrasil.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

July 16, 2018

Primary Completion

November 12, 2018

Study Completion

January 13, 2020

Last Updated

September 19, 2017

Record last verified: 2017-09