Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ICOS Corporation
• Treatments: Tadalafil

Criteria

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.