Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386009
• Other study ID #: 11233
• Secondary ID: H6D-MC-LVHK
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2006
• Last updated: July 1, 2009
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: July 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.

• Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.

• Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.

• Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria:

• Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.

• History of urethral obstruction due to stricture, valves, sclerosis, or tumor.

• Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).

• History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.

• History of angina requiring treatment with nitrates.

• Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Signs and Symptoms

Intervention

Drug:
• Tadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
• Placebo
Placebo tablet taken by mouth once a day for 12 weeks.

Locations

Country	Name	City	State
Greece	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.	Patras
Greece	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.	Thessaloniki
Portugal	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.	Coimbra
Portugal	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.	Lisbon
Portugal	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.	Porto
United States	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.	Chicago	Illinois
United States	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.	Fort Wayne	Indiana
United States	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.	Garden City	New York
United States	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.	Middlebury	Connecticut
United States	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.	Newport Beach	California
United States	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.	Orlando	Florida
United States	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.	San Antonio	Texas
United States	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.	Tarzana	California

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Countries where clinical trial is conducted

United States,  Greece,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies		Baseline and 12 weeks	No
Secondary	Presence of Involuntary Detrusor Contractions During Bladder Filling		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction		Baseline and 12 weeks	No
Secondary	Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score		12 weeks	No
Secondary	Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests		Baseline and 12 weeks	Yes

External Links

•   Lilly Clinical Trial Registry