Official Title: “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”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
• Drug: tadalafil
  • 5 mg tadalafil tablet by mouth once a day for twelve weeks.
• Drug: tadalafil
  • 10 mg tadalafil tablet by mouth once a day for twelve weeks.
• Drug: tadalafil
  • 20 mg tadalafil tablet by mouth once a day for twelve weeks.
• Drug: placebo
  • Placebo tablet taken by mouth one a day for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • placebo tablet
• Active Comparator: 2
  • 2.5 mg tadalafil tablet
• Active Comparator: 3
  • 5 mg tadalafil tablet
• Active Comparator: 4
  • 10 mg tadalafil tablet
• Active Comparator: 5
  • 20 mg tadalafil tablet

Primary Measures

• International Prostate Symptom Score (IPSS)
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• International Prostate Symptom Score (IPSS) (Irritative) sub score.
  • Time Frame: 12 weeks
    Safety Issue?: No
• International Prostate Symptom Score (IPSS) Voiding (Obstructive) sub score
  • Time Frame: 12 weeks
    Safety Issue?: No
• International Prostate Symptom Score (IPSS) Question 7 (Nocturia)
  • Time Frame: 12 weeks
    Safety Issue?: No
• International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
  • Time Frame: 12 weeks
    Safety Issue?: No
• BPH Impact Index (BII)
  • Time Frame: 12 weeks
    Safety Issue?: No
• LUTS Global Assessment Question (LUTS-GAQ)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Uroflowmetry parameters
  • Time Frame: 12 weeks
    Safety Issue?: No
• International Index of Erectile Function (IIEF) EF Domain
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety Testing
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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 IPSS score 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 LUTS therapy or PDE5 inhibitors for specified duration of time prior to Visit 2.
• Have a 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 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 November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384930

Study ID Number: 9797

ClinicalTrials.gov Identifier: NCT00384930

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry