Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Eli Lilly and Company
Collaborator:	ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00384930

Purpose

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.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: tadalafil Drug: placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Tadalafil

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	1058
Study Start Date:	August 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator placebo tablet	Drug: placebo Placebo tablet taken by mouth one a day for twelve weeks
2: Active Comparator 2.5 mg tadalafil tablet	Drug: tadalafil 2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
3: Active Comparator 5 mg tadalafil tablet	Drug: tadalafil 5 mg tadalafil tablet by mouth once a day for twelve weeks.
4: Active Comparator 10 mg tadalafil tablet	Drug: tadalafil 10 mg tadalafil tablet by mouth once a day for twelve weeks.
5: Active Comparator 20 mg tadalafil tablet	Drug: tadalafil 20 mg tadalafil tablet by mouth once a day for twelve weeks.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384930

Locations

United States, Indiana
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

Sponsors and Collaborators

Eli Lilly and Company

ICOS Corporation

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Porst H, McVary KT, Montorsi F, Sutherland P, Elion-Mboussa A, Wolka AM, Viktrup L. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009 Oct;56(4):727-35. Epub 2009 Apr 22.

Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008 Oct;180(4):1228-34. Epub 2008 Aug 22.

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9797, H6D-MC-LVHG
Study First Received:	October 3, 2006
Results First Received:	October 17, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00384930 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Signs and Symptoms
Hyperplasia
Phosphodiesterase Inhibitors
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases

Prostatic Hyperplasia
Tadalafil
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010