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

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.

Study Type: Interventional

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

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Tadalafil
  • 5mg once a day
• Drug: Placebo
  • once a day
• Drug: Tamsulosin
  • 0.2 mg once a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2
• Active Comparator: 3

Primary Measures

• IPSS total score
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• IPSS total score
  • Time Frame: 4 and 8 weeks
    Safety Issue?: No
• IPSS subscores
  • Time Frame: 4, 8, and 12 weeks
    Safety Issue?: No
• BPH-II, Patient Diary, Uroflowmetry parameters, and symptom improvement scales
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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 IPSS total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

• Prostate Specific Antigen (PSA) greater than 10.0 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.

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00540124

Study ID Number: 11658

ClinicalTrials.gov Identifier: NCT00540124

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Lilly Clinical Trial Registry