Official Title: “A Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Tadalafil Administered Once Daily to Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia”

Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.
• Drug: placebo
  • Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.
• Active Comparator: 2
  • Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.

Primary Measures

• International Prostate Symptom Score (IPSS) sum total of questions 1-7
  • Time Frame: 6 and 12 weeks
    

Secondary Measures

• Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.
  • Time Frame: 12 weeks
    
• Measure Uroflowmetry parameters
  • Time Frame: 12 weeks
    
• Evaluate safety by PSA levels and postvoid residual volume (PVR)
  • Time Frame: 12 weeks
    

Inclusion Criteria:

• 6 month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist.
• Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study.
• Meet required prostate symptom score and urine flow rate.

Exclusion Criteria:

• Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months.
• Prostate removal and various other pelvic surgeries.
• Neurological disease or condition known to affect the bladder.
• Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis.
• Have taken medications such as nitrates, finasteride, or dutasteride within the year.

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547625

Study ID Number: 9120

ClinicalTrials.gov Identifier: NCT00547625

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry