A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Overview
- Phase
- Phase 2
- Intervention
- placebo
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1058
- Locations
- 1
- Primary Endpoint
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
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
- •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
- •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
Arms & Interventions
1
placebo tablet
Intervention: placebo
2
2.5 mg tadalafil tablet
Intervention: tadalafil
3
5 mg tadalafil tablet
Intervention: tadalafil
4
10 mg tadalafil tablet
Intervention: tadalafil
5
20 mg tadalafil tablet
Intervention: tadalafil
Outcomes
Primary Outcomes
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis
Time Frame: Baseline and 12 weeks
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis
Time Frame: Baseline and 12 weeks
Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
Secondary Outcomes
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore(baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)(baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore(12 weeks)
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)(baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index(baseline and 12 weeks)
- Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)(12 weeks)
- Change From Baseline to 12 Week Endpoint in Peak Urinary Flow(baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain(baseline and 12 weeks)