| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02504541 | Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism | PHASE3 | COMPLETED | 133 | — | — | Jul 1, 2015 | Jun 1, 2016 | Mar 30, 2018 | 20 | United States |
| NCT02159469 | Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism | PHASE3 | COMPLETED | 150 | — | — | Jul 1, 2014 | Nov 1, 2015 | Feb 7, 2018 | 28 | United States |
| NCT02777242 | Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism | PHASE2 | COMPLETED | 66 | — | — | Jun 1, 2016 | Aug 1, 2016 | Mar 22, 2018 | 3 | United States |
| NCT02233751 | Pharmacokinetic Study of Subcutaneous Testosterone Enanthate | PHASE1 | COMPLETED | 12 | — | — | Sep 1, 2014 | Oct 1, 2014 | Apr 19, 2019 | 1 | United States |
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)
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.
Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity
| Arm | Type | Description |
|---|---|---|
| Testosterone enanthate auto-injector | EXPERIMENTAL | 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. |
| Testosterone enanthate auto-injector - 50 mg | EXPERIMENTAL | Testosterone enanthate auto-injector - 50 mg (SC injection) |
| Testosterone enanthate auto-injector - 200 mg | EXPERIMENTAL | Testosterone enanthate auto-injector- 200 mg (SC injection) |
| Name | Type | Description |
|---|---|---|
| Testosterone enanthate auto-injector | COMBINATION_PRODUCT | Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels |
Inclusion Criteria: * Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism * Total testosterone levels \< 300 ng/dL at two qualification visits * Patients in good general health Exclusion Criteria: * Allergy to sesame or testosterone products * BMI ≥ 40 kg/m2 * Hematocrit ...