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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00670306 | Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) | PHASE3 | COMPLETED | 528 | — | — | Mar 1, 2008 | Aug 1, 2009 | Apr 5, 2011 | 69 | United States, Canada |
International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26
| Arm | Type | Description |
|---|---|---|
| Cetrorelix 78 mg | EXPERIMENTAL | Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26. |
| Name | Type | Description |
|---|---|---|
| Cetrorelix Pamoate | DRUG | Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2, |
Inclusion Criteria: * Benign Prostatic Hyperplasia, based on medical history * Voiding symptoms * Uroflow (max) 5-15mL/sec Exclusion Criteria: * Urgent need for prostate surgery * History of allergic reaction to peptide * Major organ dysfunction * Prior surgical treatment of the prostate or bladd...