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OpenTrials
Completed

NCT Number: NCT00547625

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

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

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostate Prostatic Diseases Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil

Drug

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

Placebo

Drug

Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Primary outcomes

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

    Time frame: 6 and 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study 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

Acronym: PILUTS

Important dates

Study start
2004
Study completion
2005
First posted
Oct 22, 2007
Registry last updated
Oct 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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