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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00663858 | Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) | PHASE3 | COMPLETED | 420 | — | — | Mar 1, 2008 | Jan 1, 2010 | Jan 17, 2011 | 54 | Belarus, Bulgaria +8 |
IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)
| Arm | Type | Description |
|---|---|---|
| Cetrorelix 78+78 | EXPERIMENTAL | - |
| Cetrorelix 78 + Placebo | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cetrorelix 78+78 | DRUG | Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg) |
| Cetrorelix 78 + Placebo | DRUG | Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28 |
| Placebo | OTHER | Placebo on Week 0, Week 2, Week 26 and Week 28 |
Inclusion Criteria: * Benign Prostatic Hyperplasia, based on medical history * Voiding symptoms Exclusion Criteria: * Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder * Major organ dysfunction * Eczema (atopic dermatitis) treated during the last 6 months * C...