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A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tadalafil 5 mg

Placebo tablet

Tamsulosin

Placebo capsule

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
Have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.
Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced urine flow (measured by special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates
Have unstable angina or angina that requires treatment.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have very high or very low blood pressure.
Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.
Have uncontrolled diabetes.
Have prostate cancer, are being treated for cancer.
Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

Tadalafil 5 milligram (mg)

Tamsulosin 0.4 mg

Arm Description

Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks

Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks

Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks

The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Secondary Outcome Measures

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks

The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks

IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.

IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks

The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks

IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week

The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks

BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks

BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Patient Global Impression of Improvement (PGI-I) at 12 Weeks

The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant's symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".

Clinician Global Impression of Improvement (CGI-I) at 12 Weeks

The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant's symptoms based on a 7-point scale. A score of 1=participant felt symptoms were "very much better"; score of 2=participant felt symptoms were "much better"; score of 3=participant felt symptoms were "a little better"; score of 4=participant felt "no change" in symptoms; score of 5=participant felt symptoms were "a little worse"; score of 6=participant felt symptoms were "much worse"; score of 7=participant felt symptoms were "very much worse".

Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall

The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.

Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks

IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks

Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.

Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks

Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL.

Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks

V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.

Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks

PVR was the amount of urine remaining in the bladder after void completion.

Full Information

NCT ID

NCT00970632

First Posted

September 1, 2009

Last Updated

March 8, 2012

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00970632

Brief Title

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia (BPH)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

511 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks

Arm Title

Tadalafil 5 milligram (mg)

Arm Type

Experimental

Arm Description

Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks

Arm Title

Tamsulosin 0.4 mg

Arm Type

Active Comparator

Arm Description

Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Tadalafil 5 mg

Other Intervention Name(s)

Cialis, LY450190

Intervention Description

Tadalafil 5 mg po QD for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Intervention Description

Placebo tablet po QD for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Tamsulosin

Intervention Description

Tamsulosin 0.4 mg po QD for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo capsule

Intervention Description

Placebo capsule po QD for 12 weeks

Primary Outcome Measure Information:

Title

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks

Description

The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Time Frame

Baseline, 4 weeks

Title

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week

Description

Time Frame

Baseline, 1 week

Title

Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks

Description

Time Frame

Baseline, 4 weeks

Title

Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks

Description

BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.

Time Frame

Baseline, 12 weeks

Title

Patient Global Impression of Improvement (PGI-I) at 12 Weeks

Description

Time Frame

12 weeks

Title

Clinician Global Impression of Improvement (CGI-I) at 12 Weeks

Description

Time Frame

12 weeks

Title

Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall

Description

Time Frame

12 weeks

Title

Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks

Description

PVR was the amount of urine remaining in the bladder after void completion.

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study. Provide signed informed consent at the start of the study. Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study. Have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed. Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed. Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed. Have reduced urine flow (measured by special toilet equipment). Demonstrate compliance with study drug administration requirements. Exclusion Criteria: Treated with nitrates Have unstable angina or angina that requires treatment. Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention). Have very high or very low blood pressure. Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study. Have uncontrolled diabetes. Have prostate cancer, are being treated for cancer. Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Bentleigh East

State/Province

Victoria

ZIP/Postal Code

3165

Country

Australia

Facility Name

City

Bunbury

State/Province

Western Australia

ZIP/Postal Code

6230

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

1220

Country

Austria

Facility Name

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06002

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45067

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

City

Bad Rappenau

ZIP/Postal Code

74906

Country

Germany

Facility Name

City

Bad Wiessee

ZIP/Postal Code

D-83707

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

City

Muehlacker

ZIP/Postal Code

D-75417

Country

Germany

Facility Name

City

Oranienburg

ZIP/Postal Code

D-16515

Country

Germany

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

City

Larissa

ZIP/Postal Code

41221

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

City

Bergamo

ZIP/Postal Code

24128

Country

Italy

Facility Name

City

Cagliari

Country

Italy

Facility Name

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

City

Sassari

ZIP/Postal Code

07100

Country

Italy

Facility Name

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

City

Morelia

ZIP/Postal Code

58000

Country

Mexico

Facility Name

City

Saltillo

ZIP/Postal Code

25210

Country

Mexico

Facility Name

City

Zapopan

ZIP/Postal Code

45070

Country

Mexico

Facility Name

City

Arnhem

ZIP/Postal Code

6803 AA

Country

Netherlands

Facility Name

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

City

S-Hertogenbosch

ZIP/Postal Code

5211 NL

Country

Netherlands

Facility Name

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

City

Kutno

ZIP/Postal Code

99-300

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-005

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

26299520

Citation

Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

Results Reference

derived

PubMed Identifier

23346990

Citation

Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.

Results Reference

derived

PubMed Identifier

22297243

Citation

Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.

Results Reference

derived

Learn more about this trial

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

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