Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia With Tadalafil Daily. - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00827242

Purpose

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining,urinary frequency, feeling like your bladder is still full etc.)

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Placebo Drug: tadalafil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled,Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia.

Resource links provided by NLM:

MedlinePlus related topics: Prostate Diseases Reproductive Health

Drug Information available for: Tadalafil

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

International Prostate Symptom Score (IPSS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Benign Prostatic Hyperplasia Impact Index (BII). [ Time Frame: 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) storage (irritative) subscore [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) voiding (obstructive) subscore [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) nocturia subscore [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) Quality of Life Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Improvement (PGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) [ Time Frame: 1 week and 4 weeks ] [ Designated as safety issue: No ]
International Index of Erectile Function (IIEF) EF domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Peak flow rate(Qmax) by Uroflowmetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean flow rate(Qmean)by Uroflowmetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Voided volume (Vcomp) by Uroflowmetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	302
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tadalafil: Experimental	Drug: tadalafil 5mg tadalafil tablet by mouth daily for twelve weeks.
Placebo: Placebo Comparator	Drug: Placebo Placebo tablet by mouth daily for twelve weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms]) based on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations),OAB therapy,ED therapy for at least 4 weeks prior to study drug is dispensed.
Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced urine flow( measured by a special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates for a cardiac conditions.
Have unstable angina or angina that requires treatment.
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 very high or very low blood pressure
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 prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer(PSA greater than 10 ng/ml at the start of study).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827242

Contacts

Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)

1-317-615-4559

Show 27 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10893, H6D-MC-LVHJ
Study First Received:	January 20, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00827242 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Signs and Symptoms
Prostatic Hyperplasia
Hyperplasia

Genital Diseases, Male
Prostatic Diseases
BPH-LUTS

Study placed in the following topic categories:

Signs and Symptoms
Hyperplasia
Phosphodiesterase Inhibitors
Prostatic Diseases

Prostatic Hyperplasia
Tadalafil
Genital Diseases, Male

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 September 11, 2009