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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01139762 | A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms | PHASE3 | COMPLETED | 696 | — | — | Sep 1, 2010 | May 1, 2012 | Feb 27, 2013 | 65 | United States, Argentina +11 |
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
| Arm | Type | Description |
|---|---|---|
| Tadalafil | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tadalafil | DRUG | 5 milligrams (mg) administered orally, once daily for 26 weeks |
| Placebo | DRUG | Administered orally, once daily for 26 weeks |
| Finasteride | DRUG | 5mg administered orally, once daily for 26 weeks |
Inclusion Criteria: * Have not taken the following treatments within the indicated duration and agree not to use at any time during the study: * All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication. * Over...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | — | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | NA | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | NA | Undisclosed |
| Profound Medical Corp | PROF | 1 | — | Undisclosed |