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Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems (PILUTS)

Primary Purpose

Prostatic Hyperplasia, Prostate

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tadalafil
placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.

Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.

Outcomes

Primary Outcome Measures

International Prostate Symptom Score (IPSS) sum total of questions 1-7

Secondary Outcome Measures

Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.
Measure Uroflowmetry parameters
Evaluate safety by PSA levels and postvoid residual volume (PVR)

Full Information

First Posted
October 18, 2007
Last Updated
October 18, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00547625
Brief Title
Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems
Acronym
PILUTS
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 Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) sum total of questions 1-7
Time Frame
6 and 12 weeks
Secondary Outcome Measure Information:
Title
Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.
Time Frame
12 weeks
Title
Measure Uroflowmetry parameters
Time Frame
12 weeks
Title
Evaluate safety by PSA levels and postvoid residual volume (PVR)
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Chicago
State/Province
Illinois
Country
United States

12. IPD Sharing Statement

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Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

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