Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems
- Registration Number
- NCT00547625
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 275
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control. 2 tadalafil Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.
- Primary Outcome Measures
Name Time Method International Prostate Symptom Score (IPSS) sum total of questions 1-7 6 and 12 weeks
- Secondary Outcome Measures
Name Time Method Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. 12 weeks Measure Uroflowmetry parameters 12 weeks Evaluate safety by PSA levels and postvoid residual volume (PVR) 12 weeks
Trial Locations
- Locations (1)
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