Study 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, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384930
• Other study ID #: 9797
• Secondary ID: H6D-MC-LVHG
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 3, 2006
• Last updated: August 26, 2009
• Start date: August 2006
• Est. completion date: October 2008

Study information

• Verified date: August 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: October 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

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
2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
• tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks.
• tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks.
• tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks.
• placebo
Placebo tablet taken by mouth one a day for twelve weeks

Locations

Country	Name	City	State
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.	Greenwood	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Lilly Clinical Trial Registry