Study 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); tadalafil (Drug); tadalafil (Drug); tadalafil (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
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
This is a randomized, double-blind, placebo-controlled, parallel-design, multinational,
12-week study to compare the efficacy, dose response, and safety of tadalafil once a day
versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including
lower urinary tract symptoms.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing 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 different doses of tadalafil to placebo using the International Prostate Symptom Score (IPSS) in men with signs and symptoms of benign prostatic hyperplasia
Secondary outcome: Compare tadalafil to placebo in selected IPSS subdomain's scores, Erectile Function domain score of the IIEF, and in uroflowmetry.Safety will also be assessed by adverse event monitoring, clinical lab tests, ECGs, and other diagnostic testing.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary
tract symptoms for at least 6 months prior to Visit 1 and an IPSS score greater than
or equal to 13 at Visit 2.
- Agree not to use approved or experimental benign prostatic hyperplasia or erectile
dysfunction treatments anytime during the study
- Have not taken finasteride or dutasteride therapy, any other LUTS therapy or PDE5
inhibitors for specified duration of time prior to Visit 2.
- Have a PSA score within acceptable range defined for study or negative biopsy of the
prostate for cancer within 12 months of Visit 1.
Exclusion Criteria:
- History of urinary retention or lower urinary tract (bladder) stones 6 months before
the start of the study
- History of bladder outlet obstruction or urethral obstruction due to stricture,
valves, sclerosis, or tumor.
- History of cardiac conditions including angina requiring certain treatment with
nitrates, heart disease or coronary conditions including myocardial infarction, bypass
surgery, angioplasty or stent placement for a specified time before starting the
study.
- Certain neurological conditions associated with bladder problems or injuries to the
brain or spinal cord within a specified time before starting the study.
- Nitrate use
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., Greenwood, Indiana, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: August 2006
Ending date: October 2008
Last updated: October 23, 2007
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