Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems (PILUTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|