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Trial record 42 of 213 for:    "Hypogonadism" | "Androgens"

Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02777242
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : February 26, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypogonadism
Intervention Combination Product: Testosterone enanthate auto-injector
Enrollment 66
Recruitment Details In total, 66 patients were enrolled, of which 65 patients were randomized and were included in the Safety Population.
Pre-assignment Details The Safety Population included all patients who were randomized and took at least one dose of Investigational Product. The Safety Population was used as the denominator in percentage calculations.
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
Period Title: Overall Study
Started 65
Completed 59
Not Completed 6
Reason Not Completed
Other             2
Lost to Follow-up             1
Multiple             1
Sponsor's request             1
Withdrawal by Subject             1
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
55.3  (8.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female 0
Male 65
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Hispanic or Latino 1
Not Hispanic or Latino 64
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 17
White 48
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 65 participants
65
1.Primary Outcome
Title Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Hide Description Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description:
Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
Overall Number of Participants Analyzed 65
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with any TEAE
5
   7.7%
Patients with any TEAE related to QST
1
   1.5%
Patients with SAE
0
   0.0%
Patients with TEAE leading to discontinuation
0
   0.0%
Patients with QST related TEAE and discontinuation
0
   0.0%
Time Frame 3 Weeks
Adverse Event Reporting Description An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
 
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)]
All-Cause Mortality
Testosterone Enanthate Auto-injector
Affected / at Risk (%)
Total   0/65 (0.00%)    
Hide Serious Adverse Events
Testosterone Enanthate Auto-injector
Affected / at Risk (%) # Events
Total   0/65 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Testosterone Enanthate Auto-injector
Affected / at Risk (%) # Events
Total   5/65 (7.69%)    
Cardiac disorders   
Atrial fibrillation  1  1/65 (1.54%)  1
Ear and labyrinth disorders   
Vertigo  1  1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal turbinate hypertrophy  1  1/65 (1.54%)  1
Skin and subcutaneous tissue disorders   
Cellulitis  1  1/65 (1.54%)  1
Dermatitis contact  1  1/65 (1.54%)  1
Urticaria  1  1/65 (1.54%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Jaffe, MD
Organization: Antares Pharma, Inc.
Phone: 609-359-3020
EMail: jjaffe@antarespharma.com
Layout table for additonal information
Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT02777242    
Other Study ID Numbers: QST-16-006
First Submitted: May 12, 2016
First Posted: May 19, 2016
Results First Submitted: December 19, 2017
Results First Posted: February 26, 2018
Last Update Posted: March 22, 2018