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Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

NCT ID: NCT00540124

Last Updated: 2010-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tadalafil

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

5 mg once a day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once a day

Tamsulosin

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

0.2 mg once a day

Interventions

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Tadalafil

5 mg once a day

Intervention Type DRUG

Placebo

once a day

Intervention Type DRUG

Tamsulosin

0.2 mg once a day

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis

Eligibility Criteria

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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 International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

Exclusion Criteria

* Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (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 1.
* Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Jeonju, , South Korea

Site Status

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.

Kwangju, , South Korea

Site Status

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, , South Korea

Site Status

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, , South Korea

Site Status

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, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H6D-MC-LVHT

Identifier Type: OTHER

Identifier Source: secondary_id

11658

Identifier Type: -

Identifier Source: org_study_id