Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Tadalafil (Drug); placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
Summary
The purpose of this study is to evaluate the function of the bladder and urethra during
urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia
treated with either placebo or tadalafil.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Compare the effect of 20 mg tadalafil to placebo on the detrusor pressure at peak urinary flow rate and to assess the effect of 20 mg tadalafil on urinary flow and bladder parameters.
Secondary outcome: Assess the efficacy of 20 mg tadalafil as examined by the International Prostate Symptom Score.Assess the safety of 20 mg tadalafil in terms of adverse events and clinical laboratory tests.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men 40 years of age or older with LUTS with a total IPSS greater than or equal to 13
at Visit 1.
- Agree not to use any other approved or experimental medications for Benign Prostate
Hyperplasia-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase
inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
- Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit
2; have not taken any other LUTS therapy (including herbal preparations)or PDE5
inhibitors for at least 4 weeks prior to Visit 2.
- Have had BPH-LUTS for greater than 6 months prior to Visit 1.
Exclusion Criteria:
- Any pelvic surgical procedure on the urinary tract, including minimally invasive
BPH-LUTS therapies and penile implant surgery.
- History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
- Current neurologic disease or condition associated with neurogenic bladder (for
example, Parkinson's disease, multiple sclerosis).
- History of cardiac conditions including myocardial infarction, bypass surgery,
angioplasty or stent placement for a specified time before starting the study.
- History of angina requiring treatment with nitrates.
- PSA greater than 10 ng/ml at Visit 1.
Locations and Contacts
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., Patras 26500, Greece
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., Thessaloniki 56429, Greece
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., Coimbra 3000-076, Portugal
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., Lisbon 1549-008, Portugal
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., Porto 4200-319, Portugal
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., Newport Beach, California 92660, 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., Tarzana, California 91356, 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., Middlebury, Connecticut 06762, 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., Orlando, Florida 32803, 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 60611, 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., Fort Wayne, Indiana 46825, 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., Garden City, New York 11530, 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., San Antonio, Texas 78229, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: October 2006
Ending date: June 2008
Last updated: May 22, 2008
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