Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01887418 | Pharmacokinetic Study of Testosterone Enanthate | PHASE1 | COMPLETED | 39 | — | — | Sep 1, 2013 | Jan 1, 2014 | Jan 11, 2018 | 1 | United States |
The area under the curve from time zero to last quantifiable concentration \[AUC (0-t)\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The maximum observed plasma concentration \[Cmax\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The average concentration \[Cavg\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
| Arm | Type | Description |
|---|---|---|
| QuickShot™ - 100 mg Treatment A | EXPERIMENTAL | QuickShot™Testosterone - Auto-injector device for SC use |
| QuickShot™ - 50 mg Treatment B | EXPERIMENTAL | QuickShot™Testosterone- Auto-injector device for SC use |
| Delatestryl 200 mg IM Treatment C | ACTIVE_COMPARATOR | Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference |
| Name | Type | Description |
|---|---|---|
| QuickShot™ - 50 mg Treatment B | DRUG | QuickShot™ for the delivery of testosterone |
| QuickShot™ - 100 mg Treatment A | DRUG | QuickShot™ for the delivery of testosterone |
| Delatestryl 200 mg IM Treatment C | DRUG | Standard of care |
Inclusion Criteria: * Adult males aged 18 to 75 with a documented diagnosis of hypogonadism Exclusion Criteria: * Normal testosterone levels * Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for e...