Status:
COMPLETED
Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ICOS Corporation
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief 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 pl...
Eligibility Criteria
Inclusion
- Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
- Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-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
- 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.
- Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00386009
Start Date
October 1 2006
End Date
May 1 2008
Last Update
July 9 2009
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
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.
Newport Beach, California, United States, 92660
2
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, United States, 91356
3
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, United States, 06762
4
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, United States, 32803