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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: tadalafil (Drug); tadalafil (Drug); tadalafil (Drug); tadalafil (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

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

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

Primary outcome:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis

Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis

Secondary outcome:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index

Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)

Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

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
Additional Information

Lilly Clinical Trial Registry

Starting date: August 2006
Last updated: August 26, 2009

Page last updated: August 23, 2015

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