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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00547625
Collaborator
ICOS Corporation (Industry)
275
Enrollment
1
Location
2
Arms
9
Duration (Months)
30.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Oct 1, 2004
Actual Study Completion Date :
Jul 1, 2005

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. International Prostate Symptom Score (IPSS) sum total of questions 1-7 [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. [12 weeks]

    2. Measure Uroflowmetry parameters [12 weeks]

    3. Evaluate safety by PSA levels and postvoid residual volume (PVR) [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00547625
    Other Study ID Numbers:
    • 9120
    • H6D-MC-LVGC
    First Posted:
    Oct 22, 2007
    Last Update Posted:
    Oct 22, 2007
    Last Verified:
    Oct 1, 2007
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tadalafil

    Study Results

    No Results Posted as of Oct 22, 2007