Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Tucson, Arizona, United States
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
Time frame: 26 weeks
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Unnamed facility
San Diego, California, United States
Unnamed facility
Aventura, Florida, United States
Unnamed facility
Brandon, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Shreveport, Louisiana, United States
Unnamed facility
Elkridge, Maryland, United States
Unnamed facility
Garden City, New York, United States
...and 10 more locations