Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
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.
Time frame: 12 weeks
Safety and Tolerability
* Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study
Time frame: 52 weeks
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Huntsville, Alabama, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Burbank, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Upland, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Oviedo, Florida, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Shreveport, Louisiana, United States
...and 18 more locations