A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Eli Lilly and Company1 site in 1 country151 target enrollmentOctober 2007

ConditionsBenign Prostatic Hyperplasia

InterventionsTadalafil Placebo Tamsulosin

DrugsTadalafil Placebo Tamsulosin

Overview

Phase: Phase 2
Intervention: Tadalafil
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Enrollment: 151
Locations: 1
Primary Endpoint: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

June 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit
•Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
•Have not taken Finasteride therapy for at least 3 months prior to Visit
•Have not taken Dutasteride therapy for at least 6 months prior to Visit
•Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

Exclusion Criteria

•Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit
•Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit
•History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
•Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit
•Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.

Arms & Interventions

Tadalafil

Intervention: Tadalafil

Placebo

Intervention: Placebo

Tamsulosin

Intervention: Tamsulosin

Outcomes

Primary Outcomes

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

Time Frame: baseline, 12 weeks

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Secondary Outcomes

Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score(baseline, 4 and 8 weeks)
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore(baseline, 4, 8, and 12 weeks)
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore(baseline, 4, 8, and 12 weeks)
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary(baseline, 12 weeks)
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore(baseline, 4, 8, and 12 weeks)
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)(baseline, 12 weeks)
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary(baseline, 12 weeks)
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary(baseline, 12 weeks)
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)(baseline, 12 weeks)
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies(12 weeks)
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies(12 weeks)
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)(baseline, 12 weeks)