Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems (PILUTS)
|ClinicalTrials.gov Identifier: NCT00547625|
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia Prostate||Drug: tadalafil Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||275 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official 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|
|Study Start Date :||October 2004|
|Actual Study Completion Date :||July 2005|
Placebo Comparator: 1
Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.
Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.
Active Comparator: 2
Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547625
|United States, Illinois|
|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|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|