Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia”

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Tadalafil
  • 20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
• Drug: Placebo
  • Placebo tablet taken by mouth once a day for 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Active Comparator: 2
  • tadalafil

Primary Measures

• Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Presence of Involuntary Detrusor Contractions During Bladder Filling
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
  • Time Frame: 12 weeks
    Safety Issue?: No
• Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total
• International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
• Agree not to use any other approved or experimental medications for Benign Prostate
• Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
• Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
• Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria:

• Any pelvic surgical procedure on the urinary tract, including minimally invasive
• BPH-LUTS therapies and penile implant surgery.
• History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
• Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
• History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
• History of angina requiring treatment with nitrates.
• Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386009

Study ID Number: 11233

ClinicalTrials.gov Identifier: NCT00386009

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry