Phase 3
N=1,058
Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00384930 ↗Enrolled (actual)
1,058
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis — 17.08; 17.30; -2.25; -4.92 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tadalafil (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis |
17.08; 17.30; -2.25; -4.92 | <0.001 sig |
| PRIMARY Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis |
-2.23; -3.81; -4.83; -5.13; -5.17 | 0.005 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore |
7.58; 7.78; 7.65; 7.88; 7.53; -0.99 | 0.025 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore |
9.51; 9.71; 9.65; 9.88; 9.57; -1.27 | 0.008 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) |
2.36; 2.37; 2.36; 2.36; 2.20; -0.36 | 0.503 |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index |
3.57; 3.69; 3.54; 3.55; 3.59; -0.56 | 0.029 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) |
4.94; 4.73; 4.66; 4.86; 4.75; -0.79 | 0.583 |
| SECONDARY Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) |
109; 120; 139; 146; 138 | 0.133 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Peak Urinary Flow |
10.31; 9.97; 10.37; 9.93; 9.82; 1.23 | 0.735 |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain |
17.26; 17.42; 15.29; 17.22; 16.28; 0.78 | <0.001 sig |
Summary
This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.
Eligibility Criteria
Inclusion Criteria
- Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
- Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
- Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
- Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
Exclusion Criteria
- History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
- History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
- History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
- Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
- Nitrate use
Data sourced from ClinicalTrials.gov (NCT00384930). 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.