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

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostatic Hyperplasia, Prostate

In brief

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

Key facts

Study ID

NCT00547625

Run by

Eli Lilly and Company

People needed

275

Starts

2004-10-01

Expected to finish

2005-07-01

Last updated by the study team

2007-10-22

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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