Phase 2
Completed N=151
Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men
Source: ClinicalTrials.gov NCT00540124 ↗Enrolled (actual)
151
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score — 17.3; 17.1; 17.7; -4.2 units on a scale — p=0.073
Summary
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score |
17.3; 17.1; 17.7; -4.2; -5.8; -5.6 | 0.073 |
| SECONDARY Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score |
-2.8; -4.0; -4.0; -3.3; -4.8; -4.8 | 0.155 |
| SECONDARY Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore |
6.7; 6.7; 6.5; -0.8; -1.4; -1.7 | 0.137 |
| SECONDARY Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore |
10.6; 10.4; 11.2; -2.0; -2.6; -2.4 | 0.306 |
| SECONDARY Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore |
2.0; 1.8; 1.7; -0.3; -0.4; -0.3 | 0.206 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) |
6.2; 6.1; 6.2; -2.0; -2.2; -1.7 | 0.691 |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies |
1; 1; 3; 10; 5; 7 | 0.176 |
| SECONDARY Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies |
0; 0; 4; 5; 8; 4 | 0.429 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary |
48.2; 46.9; 48.4; -0.3; -2.1; -1.3 | 0.254 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary |
0.8; 1.1; 1.6; -0.3; 0.7; -0.3 | 0.208 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary |
68.7; 69.8; 77.5; -11.7; 1.6; -8.5 | 0.385 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) |
10.5; 11.4; 11.7; 2.8; 2.4; 1.9 | 0.838 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) |
220.0; 233.2; 236.6; 21.4; 19.7; 23.9 | 0.709 |
Eligibility Criteria
Inclusion Criteria
- Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
- Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
- Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
- Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
- Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.
Exclusion Criteria
- Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
- Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
- History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
- Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
- Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
Data sourced from ClinicalTrials.gov (NCT00540124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.