Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone enanthate auto-injector · 4 trials · 1 indication
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 ...
Testosterone enanthate auto-injector is used for the treatment of hypogonadism in adult men. It is an investigational small molecule being developed by Halozyme Therapeutics, Inc. (NASDAQ: HALO). The drug is currently in Phase 3 clinical development, with four completed trials involving a total of 361 participants.
Testosterone enanthate auto-injector works by delivering testosterone enanthate, a form of testosterone, subcutaneously to replace deficient testosterone levels in men with hypogonadism. This helps restore normal testosterone concentrations, alleviating symptoms associated with low testosterone.
Testosterone enanthate auto-injector is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol HALO. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of hypogonadism.
Testosterone enanthate auto-injector is in Phase 3 clinical development for hypogonadism. It is an investigational drug and has not been approved by the FDA. The development program includes completed Phase 1, Phase 2, and Phase 3 trials, with the most advanced studies being Phase 3.
Testosterone enanthate auto-injector has completed four clinical trials. These include NCT02159469, a Phase 3 study with 150 participants; NCT02233751, a Phase 1 pharmacokinetic study with 12 participants; NCT02504541, a Phase 3 safety study with 133 participants; and NCT02777242, a Phase 2 safety study with 66 participants. All trials were conducted in the United States.