Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
275
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.
Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.
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
International Prostate Symptom Score (IPSS) sum total of questions 1-7
Time frame: 6 and 12 weeks
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.