Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone Cypionate · 1 trial · 1 indication
The percentage of participants whose average serum total testosterone concentration (Cavg) over the 168-hour (7-day) dosing interval at Week 12 is within the predefined range of 300-1100 ng/dL. Serum total testosterone concentrations will be measured using blood samples collected before and at specified time points after dosing through 168 hours. Cavg will be calculated by dividing the area under the serum concentration-time curve from 0 to 168 hours (AUC0-168h) by 168 hours. The primary efficacy criterion is met if at least 75% of participants achieve the specified range, with the lower bound of the two-sided 95% confidence interval at least 65%. The assessment will be based on the protocol-defined full pharmacokinetic population.
| Arm | Type | Description |
|---|---|---|
| Testosterone Cypionate Auto-Injector (75 mg) | EXPERIMENTAL | Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. |
| Testosterone Cypionate Auto-Injector (50 mg) | EXPERIMENTAL | Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to 50 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. |
| Testosterone Cypionate Auto-Injector (100 mg) | EXPERIMENTAL | Participants with hypogonadism will receive testosterone cypionate injection administered subcutaneously into the abdomen once weekly using an auto-injector. All participants will initiate treatment at 75 mg once weekly. The dose may be adjusted to100 mg based on serum total testosterone trough concentrations and protocol-defined dose titration criteria. Treatment will continue through the 24-week primary evaluation period. Participants completing Week 24 may continue once-weekly treatment with ongoing safety assessments through Week 52. The first dose will be administered by designated study personnel, followed by participant self-administration as specified in the protocol. |
| Name | Type | Description |
|---|---|---|
| Testosterone Cypionate 75 mg | DRUG | Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 75 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment. |
| Testosterone cypionate 50 mg | DRUG | Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 50 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment. |
| Testosterone cypionate 100 mg | DRUG | Testosterone cypionate injectable solution formulated in cottonseed oil, supplied in a single-use auto-injector containing 100 mg/0.5 mL. The study drug will be administered subcutaneously into the abdomen once weekly. All participants will initiate treatment at 75 mg once weekly, with dose adjustments in 25 mg increments to 50 mg or 100 mg based on serum total testosterone trough concentrations according to protocol-defined criteria. Treatment will continue through the 24-week primary evaluation period, with eligible participants permitted to continue once-weekly treatment through Week 52 for extended safety assessment. |
Inclusion Criteria: * Adults assigned male at birth, aged 18 to 75 years. * Documented diagnosis of hypogonadism (low testosterone) with at least one associated symptom, such as reduced sexual desire, erectile dysfunction, fatigue, reduced energy, loss of muscle mass, decreased body hair, or mood c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Halozyme Therapeutics, Inc. | HALO | 1 | PHASE3 | Xyosted |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | mibavademab |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Testosterone Cypionate |