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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03792477 | A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males | PHASE1 | COMPLETED | 74 | — | — | Jan 19, 2019 | Apr 2, 2020 | Apr 29, 2021 | 2 | United States |
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
| Arm | Type | Description |
|---|---|---|
| Part 1: Treatment A | EXPERIMENTAL | Single 200mg IM testosterone cypionate solution (Test formulation) |
| Part 1: Treatment B | ACTIVE_COMPARATOR | Single 200 mg IM testosterone cypionate solution (Reference formulation) |
| Part 2: Treatment A | EXPERIMENTAL | Single 200 mg IM testosterone cypionate solution (Test formulation) |
| Part 2: Treatment B | ACTIVE_COMPARATOR | Single 200 mg IM testosterone cypionate solution (Reference formulation) |
| Name | Type | Description |
|---|---|---|
| Test formulation | BIOLOGICAL | A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation). |
| Reference formulation | BIOLOGICAL | A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation). |
Inclusion Criteria: 1. Hypogonadal male subjects who, at the time of screening, are otherwise healthy and between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood p...