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

Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547625
• Other study ID #: 9120
• Secondary ID: H6D-MC-LVGC
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2007
• Last updated: October 18, 2007
• Start date: October 2004
• Est. completion date: July 2005

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostate
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS) sum total of questions 1-7		6 and 12 weeks
Secondary	Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.		12 weeks
Secondary	Measure Uroflowmetry parameters		12 weeks
Secondary	Evaluate safety by PSA levels and postvoid residual volume (PVR)		12 weeks

External Links

•   Lilly Clinical Trial Registry