Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
STEADY
A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
1 other identifier
interventional
150
1 country
28
Brief Summary
Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2014
Shorter than P25 for phase_3
28 active sites
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
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
January 9, 2018
CompletedFebruary 7, 2018
January 1, 2018
7 months
June 6, 2014
December 12, 2017
January 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
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.
12 weeks
Secondary Outcomes (1)
Safety and Tolerability
52 weeks
Study Arms (1)
Testosterone enanthate auto-injector
EXPERIMENTALTestosterone 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.
Interventions
Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels
Eligibility Criteria
You may qualify if:
- Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
- Total testosterone levels \< 300 ng/dL at two qualification visits
- Patients in good general health
You may not qualify if:
- Allergy to sesame or testosterone products
- BMI ≥ 40 kg/m2
- Hematocrit ≥ 52%
- History or current evidence of breast or prostate cancer
- Elevated PSA (Prostate-Specific Antigen) for age.
- Abnormal DRE (digital rectal examination)
- Obstructive uropathy of prostatic origin
- Poorly controlled diabetes
- Congestive heart failure
- Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
- History or current treatment of thromboembolic disease.
- Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening.
- History of severe, untreated sleep apnea
- Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
- Positive serology for HIV, hepatitis B or hepatitis C
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Burbank, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Oviedo, Florida, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Brookline, Massachusetts, United States
Unknown Facility
Methuen, Massachusetts, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Lawrenceville, New Jersey, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Franklin, Ohio, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Sugar Land, Texas, United States
Unknown Facility
West Valley City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Renton, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Jaffe, MD
- Organization
- Antares Pharma, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Jed Kaminetsky, MD
Manhattan Medical Research Practice
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2014
First Posted
June 10, 2014
Study Start
July 1, 2014
Primary Completion
February 1, 2015
Study Completion
November 1, 2015
Last Updated
February 7, 2018
Results First Posted
January 9, 2018
Record last verified: 2018-01