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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03868059 | Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men | PHASE3 | COMPLETED | 138 | — | — | Apr 30, 2018 | Feb 21, 2019 | Jun 10, 2021 | 16 | United States |
| NCT03242408 | Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) | PHASE3 | COMPLETED | 100 | — | — | Jan 1, 2017 | Jul 1, 2017 | Oct 23, 2019 | - | — |
| NCT03242590 | Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). | PHASE3 | COMPLETED | 95 | — | — | Dec 1, 2016 | Jul 1, 2017 | Oct 23, 2019 | - | — |
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration \[Cavg\] in the normal range
| Arm | Type | Description |
|---|---|---|
| LPCN 1021 | EXPERIMENTAL | LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), |
| Oral testosterone undecanoate, LPCN 1021 | EXPERIMENTAL | Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day |
| Name | Type | Description |
|---|---|---|
| LPCN 1021 | DRUG | LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule. |
Inclusion Criteria: 1. Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures. 2. Male between 18 and 80 years of age, inclusive, with documented onset of h...