Status:
COMPLETED
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Lead Sponsor:
Eli Lilly and Company
Conditions:
Benign Prostatic Hyperplasia
Enlarged Prostate
Eligibility:
MALE
45+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia a...
Eligibility Criteria
Inclusion
- Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
- All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
- Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- Finasteride or dutasteride use at any time.
- Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
- Have prostate enlargement measured by ultrasound at screening.
Exclusion
- Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer \[Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study\].
- Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- Have problems with kidneys, liver, or nervous system
- Have uncontrolled diabetes
- Have had a stroke or a significant injury to brain or spinal cord.
- Have scheduled or planned surgery during the course of the study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT01139762
Start Date
September 1 2010
End Date
May 1 2012
Last Update
February 27 2013
Active Locations (65)
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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.
Davis, California, United States, 95616
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.
Fresno, California, United States, 93720
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.
Laguna Hills, California, United States, 92367
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.
Long Beach, California, United States, 90806