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. Identifier: NCT00547625
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
ICOS Corporation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Prostate Drug: tadalafil Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: placebo
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.
Drug: tadalafil
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.
Other Names:
  • LY450190
  • Cialis
  • IC351

Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) sum total of questions 1-7 [ Time Frame: 6 and 12 weeks ]

Secondary Outcome Measures :
  1. Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. [ Time Frame: 12 weeks ]
  2. Measure Uroflowmetry parameters [ Time Frame: 12 weeks ]
  3. Evaluate safety by PSA levels and postvoid residual volume (PVR) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
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

Additional Information: Identifier: NCT00547625     History of Changes
Other Study ID Numbers: 9120
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents