Prostatic Hyperplasia Clinical Trial
— PILUTSOfficial 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
Verified date | October 2007 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.
Status | Completed |
Enrollment | 275 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Prostate Symptom Score (IPSS) sum total of questions 1-7 | 6 and 12 weeks | ||
Secondary | Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. | 12 weeks | ||
Secondary | Measure Uroflowmetry parameters | 12 weeks | ||
Secondary | Evaluate safety by PSA levels and postvoid residual volume (PVR) | 12 weeks |
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