Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia in Asian Men - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00540124

Purpose

The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Tadalafil Drug: Placebo Drug: Tamsulosin	Phase II

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, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Tamsulosin Tamsulosin hydrochloride 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) Total Score [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score [ Time Frame: baseline, 4 and 8 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore [ Time Frame: baseline, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore [ Time Frame: baseline, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore [ Time Frame: baseline, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	151
Study Start Date:	October 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Tadalafil 5mg once a day
2: Placebo Comparator	Drug: Placebo once a day
3: Active Comparator	Drug: Tamsulosin 0.2 mg once a day

Eligibility

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

Criteria

Inclusion Criteria:

Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
Have an IPSS total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

Prostate Specific Antigen (PSA) greater than 10.0 ng/mL at Visit 1.
Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit
Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540124

Locations

Korea, Republic of
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.
Jeon Ju-City, Korea, Republic of, 561-712
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.
Kwang Ju, Korea, Republic of, 501-757
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.
Pusan, Korea, Republic of, 614-735
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.
Seoul, Korea, Republic of, 140-757
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.
Kyunggi-Do, Korea, Republic of, 425-020

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

Additional Information:

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11658, H6D-MC-LVHT
Study First Received:	October 3, 2007
Results First Received:	June 1, 2009
Last Updated:	June 1, 2009
ClinicalTrials.gov Identifier:	NCT00540124 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Hyperplasia
Phosphodiesterase Inhibitors
Adrenergic Agents
Prostatic Diseases

Prostatic Hyperplasia
Tadalafil
Tamsulosin
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Genital Diseases, Male

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Genital Diseases, Male

Pharmacologic Actions
Hyperplasia
Phosphodiesterase Inhibitors
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Tamsulosin
Tadalafil
Adrenergic Antagonists

ClinicalTrials.gov processed this record on August 28, 2009