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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tadalafil
Placebo
Tamsulosin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

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

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.

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Tadalafil

Placebo

Tamsulosin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Secondary Outcome Measures

Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore
The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore
The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore
IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)
The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies
Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary
Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary
A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary
A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)
Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)
Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).

Full Information

First Posted
October 3, 2007
Last Updated
November 18, 2010
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00540124
Brief Title
Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tadalafil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Tamsulosin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Other Intervention Name(s)
LY450190, Cialis
Intervention Description
5 mg once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once a day
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
0.2 mg once a day
Primary Outcome Measure Information:
Title
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Description
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score
Description
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time Frame
baseline, 4 and 8 weeks
Title
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore
Description
The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.
Time Frame
baseline, 4, 8, and 12 weeks
Title
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore
Description
The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.
Time Frame
baseline, 4, 8, and 12 weeks
Title
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore
Description
IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).
Time Frame
baseline, 4, 8, and 12 weeks
Title
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)
Description
The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.
Time Frame
baseline, 12 weeks
Title
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies
Description
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).
Time Frame
12 weeks
Title
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies
Description
Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).
Time Frame
12 weeks
Title
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary
Description
Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.
Time Frame
baseline, 12 weeks
Title
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary
Description
A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.
Time Frame
baseline, 12 weeks
Title
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary
Description
A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).
Time Frame
baseline, 12 weeks
Title
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)
Description
Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Time Frame
baseline, 12 weeks
Title
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)
Description
Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Jeon Ju-City
ZIP/Postal Code
561-712
Country
Korea, Republic of
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
Kwang Ju
ZIP/Postal Code
501-757
Country
Korea, Republic of
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
Kyunggi-Do
ZIP/Postal Code
425-020
Country
Korea, Republic of
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
Pusan
ZIP/Postal Code
614-735
Country
Korea, Republic of
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
Seoul
ZIP/Postal Code
140-757
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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