Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 213 for:    "Hypogonadism" | "Androgens"

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism (STEADY)

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: NCT02159469
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : January 9, 2018
Last Update Posted : February 7, 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 150
Recruitment Details Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).
Pre-assignment Details The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.
Arm/Group Title QST 50 mg / 75 mg / 100 mg
Hide Arm/Group Description Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Period Title: Overall Study
Started 150
Completed 12 Week 137
Completed 97
Not Completed 53
Reason Not Completed
Missing Completion status             1
Adverse Event             5
Non-compliance             2
Withdrawal by Subject             9
Lost to Follow-up             1
Sponsor's request             2
Met Stopping Criteria             3
Other             1
Multiple             29
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description

Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.

Testosterone enanthate auto-injector Dose Adjustment: 50 mg / 75 mg / 100 mg

Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
Masked dose assignment based upon Testosterone levels; Individual patients may receive all three dose levels.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
53.4  (12.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
0
   0.0%
Male
150
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Hispanic or Latino
8
   5.3%
Not Hispanic or Latino
142
  94.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
   7.3%
White
133
  88.7%
More than one race
1
   0.7%
Unknown or Not Reported
1
   0.7%
1.Primary Outcome
Title Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
Hide Description The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description:
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
139
  92.7%
2.Secondary Outcome
Title Safety and Tolerability
Hide Description
  • Incidence of adverse events throughout the study
  • Incidence and severity of injection site reactions throughout the study
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description:

Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.

Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg

Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with any TEAE
125
  83.3%
Patients with any TEAE related to IP
66
  44.0%
Patients with any SAE
3
   2.0%
Patients with TEAE leading to discontinuation
30
  20.0%
Patients discontinued due to IP related TEAE
1
   0.7%
Patients with any adverse event leading to death
1
   0.7%
Time Frame Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks
Adverse Event Reporting Description

Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.

In total, 125 (83.3%) patients had TEAEs during the study.

 
Arm/Group Title Testosterone Enanthate Auto-injector
Hide Arm/Group Description

Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.

Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg

All-Cause Mortality
Testosterone Enanthate Auto-injector
Affected / at Risk (%)
Total   1/150 (0.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone Enanthate Auto-injector
Affected / at Risk (%) # Events
Total   3/150 (2.00%)    
Ear and labyrinth disorders   
Vertigo  1 [1]  1/150 (0.67%)  1
Psychiatric disorders   
Depression  1 [2]  1/150 (0.67%)  1
Suicide  1 [3]  1/150 (0.67%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
[1]
Vertigo
[2]
Worsening depressive disorder
[3]
SUICIDE, METHOD UNKNOWN
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Testosterone Enanthate Auto-injector
Affected / at Risk (%) # Events
Total   125/150 (83.33%)    
Blood and lymphatic system disorders   
Polycythemia  1  3/150 (2.00%)  3
Gastrointestinal disorders   
Injection site hemorrhage  1  5/150 (3.33%)  5
Abdominal pain  1  3/150 (2.00%)  3
Hemorrhoids  1  3/150 (2.00%)  3
General disorders   
Injection site bruising  2  10/150 (6.67%)  10
Injection site erythema  1  4/150 (2.67%)  4
Edema peripheral  1  4/150 (2.67%)  4
Fatigue  1  3/150 (2.00%)  3
Infections and infestations   
Upper respiratory tract infection  1  12/150 (8.00%)  12
Sinusitis  1  11/150 (7.33%)  11
Nasopharyngitis  1  6/150 (4.00%)  6
Bronchitis  1  5/150 (3.33%)  5
Influenza  1  4/150 (2.67%)  4
Urinary tract infection  1  4/150 (2.67%)  4
Investigations   
Hematocrit increased  1  21/150 (14.00%)  21
Prostatic specific antigen increased  1  18/150 (12.00%)  18
Blood creatine phosphokinase increased  1  5/150 (3.33%)  5
Blood testosterone increased  1  4/150 (2.67%)  4
Musculoskeletal and connective tissue disorders   
Back pain  1  5/150 (3.33%)  5
Arthralgia  1  3/150 (2.00%)  3
Nervous system disorders   
Headache  1  8/150 (5.33%)  8
Renal and urinary disorders   
Hematuria  1  3/150 (2.00%)  3
Reproductive system and breast disorders   
Prostatitis  1  4/150 (2.67%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/150 (2.67%)  4
Sinus congestion  1  3/150 (2.00%)  3
Sleep apnea syndrome  1  3/150 (2.00%)  3
Skin and subcutaneous tissue disorders   
Acne  1  4/150 (2.67%)  4
Eczema  1  3/150 (2.00%)  3
Vascular disorders   
Hypertension  1  19/150 (12.67%)  19
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA 13.1
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: NCT02159469     History of Changes
Other Study ID Numbers: QST-13-003
First Submitted: June 6, 2014
First Posted: June 10, 2014
Results First Submitted: December 12, 2017
Results First Posted: January 9, 2018
Last Update Posted: February 7, 2018