Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism (STEADY)
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|ClinicalTrials.gov Identifier: NCT02159469|
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : January 9, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Combination Product: Testosterone enanthate auto-injector||Phase 3|
This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range.
The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.
Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Testosterone enanthate auto-injector
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.
Combination Product: Testosterone enanthate auto-injector
Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels
- Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) [ Time Frame: 12 weeks ]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.
- Safety and Tolerability [ Time Frame: 52 weeks ]
- Incidence of adverse events throughout the study
- Incidence and severity of injection site reactions throughout the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159469
Show 28 Study Locations
|Principal Investigator:||Jed Kaminetsky, MD||Manhattan Medical Research Practice|