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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00196339 | A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients | PHASE2 | COMPLETED | 315 | — | — | Jun 1, 2005 | Jan 1, 2008 | Jul 22, 2016 | 118 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| Cyproterone acetate 5 mg ( DR-2031) | EXPERIMENTAL | 1 tablet daily |
| Cyproterone acetate 15 mg ( DR-2031) | EXPERIMENTAL | 1 tablet daily |
| Cyproterone acetate 25 mg ( DR-2031) | EXPERIMENTAL | 1 tablet daily |
| Placebo | PLACEBO_COMPARATOR | 1 tablet daily |
| Name | Type | Description |
|---|---|---|
| Cyproterone acetate 5 | DRUG | Cyproterone acetate 5 mg |
| Placebo | DRUG | Matching placebo |
| Cyproterone acetate 15 | DRUG | Cyproterone acetate 15 mg |
| Cyproterone acetate 25 | DRUG | Cyproterone acetate 25 mg |
Inclusion Criteria: * Prostate cancer patients who have undergone chemical or surgical castration * History of hot flashes for at least 30 days * Stable prostate cancer therapy for at least 45 days Exclusion Criteria: * Uncontrolled diabetes or severe COPD * History of thromboembolic disease * Li...