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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00427219 | The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate | PHASE2 | COMPLETED | 74 | — | — | Jan 23, 2007 | Feb 27, 2008 | Oct 15, 2021 | 13 | United States |
IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.
| Arm | Type | Description |
|---|---|---|
| Ozarelix | EXPERIMENTAL | All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received ozarelix on Day 0 and Day 14. |
| Placebo | PLACEBO_COMPARATOR | All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14. |
| Name | Type | Description |
|---|---|---|
| Ozarelix | DRUG | Ozarelix 15 mg will be administered IM on Day 0 and Day 14. |
| Placebo | DRUG | Placebo will be administered IM on Day 0 and Day 14. |
Inclusion Criteria: \- All of the following questions must be answered "Yes" at Visit 1 in order for the participant to participate in the study. * Is the participant at least 50 years old? * Does the participant have clinical signs and symptoms consistent with BPH? * Does the participant have an ...