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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04685993 | A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial | PHASE2 | COMPLETED | 25 | — | — | Nov 11, 2020 | Mar 1, 2022 | Jul 17, 2024 | 10 | United States |
Number of subjects presenting with a treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | LPCN 1144 |
| Name | Type | Description |
|---|---|---|
| LPCN 1144 | DRUG | Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). |
Inclusion Criteria: 1. Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144 2. Subject must sign the Informed Consent Form to participate in the study Exclusion Criteria: 1. Has participated or is participating in any other clinical (investigational...