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
ClinicalTrials.gov processed this data on August 23, 2015 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: Completed
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary AnalysisChange From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis
Secondary outcome: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) SubscoreChange From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain
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 International Prostate
Symptom Score (IPSS) 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 lower urinary tract
symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified
duration of time prior to Visit 2.
- Have a prostate specific antigen (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
Last updated: August 26, 2009
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