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

This study has been completed.

Study NCT00540124 Information provided by Eli Lilly and Company

First Received on October 3, 2007. Last Updated on November 18, 2010 History of Changes

Results First Received: June 1, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Benign Prostatic Hyperplasia
Interventions:	Drug: Tadalafil Drug: Placebo Drug: Tamsulosin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were three periods to this study. Period 1 was a 4-week Screening/Washout Period. 196 subjects screened (45 failures). Period 2 was a 4-week Placebo Run-in Period. Period 3 was a 12-week Treatment Period (151 subjects randomized).

Reporting Groups

	Description
Placebo	by mouth once a day
Tadalafil	5 mg by mouth once a day
Tamsulosin	0.2 mg by mouth once a day

Participant Flow: Overall Study

	Placebo	Tadalafil	Tamsulosin
STARTED	51	51	49
COMPLETED	47	48	48
NOT COMPLETED	4	3	1
Adverse Event	0	2	1
Entry Criteria Not Met	2	0	0
Lack of Efficacy	1	0	0
Withdrawal by Subject	1	1	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	by mouth once a day
Tadalafil	5 mg by mouth once a day
Tamsulosin	0.2 mg by mouth once a day

Baseline Measures

	Placebo	Tadalafil	Tamsulosin	Total
Number of Participants [units: participants]	51	51	49	151
Age [units: years] Mean ± Standard Deviation	62.2 ± 6.8	61.2 ± 6.6	61.5 ± 6.4	61.6 ± 6.6
Gender [units: participants]
Female	0	0	0	0
Male	51	51	49	151
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0
Asian	51	51	49	151
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	0	0	0	0
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0
Region of Enrollment [units: participants]
Korea, Republic of	51	51	49	151
Erectile Dysfunction (ED) [units: participants]
Yes	36	30	24	90
No	15	21	25	61
Duration of Erectile Dysfunction (ED) ^[1] [units: participants]
<3 Months	0	1	0	1
3 Months to < 6 Months	2	3	1	6
6 Months to < 1 Year	5	3	5	13
1 Year or More	29	23	18	70
Etiology of Erectile Dysfunction (ED) ^[1] [units: participants]
Psychogenic	2	0	0	2
Organic	16	10	11	37
Mixed	17	15	12	44
Unknown	1	5	1	7
Severity of Erectile Dysfunction (ED) ^[2] [units: participants]
Mild	17	22	13	52
Moderate	14	5	7	26
Severe	5	3	4	12
Lower Urinary Tract Symptoms Severity ^[3] [units: participants]
Moderate (IPSS < 20)	35	35	33	103
Severe (IPSS ≥20)	16	16	16	48
Postvoid Residual Volume (PRV) [units: milliliters] Mean ± Standard Deviation	34.4 ± 35.7	30.9 ± 33.8	42.0 ± 59.6	35.7 ± 44.3
Height [units: centimeters] Mean ± Standard Deviation	168.6 ± 5.2	168.6 ± 5.5	167.3 ± 4.6	168.2 ± 5.1
Weight [units: kilograms] Mean ± Standard Deviation	70.7 ± 8.1	70.1 ± 7.5	68.4 ± 7.6	69.7 ± 7.7
Body Mass Index ^[4] [units: kilograms/meters squared (kg/m^2)] Mean ± Standard Deviation	24.8 ± 2.2	24.7 ± 2.3	24.4 ± 2.1	24.6 ± 2.2

[1]	Because this measure applies only to participants with ED, the number of participants reported here will be less than the total number of participants in the study.
[2]	Because this measure applies only to participants with ED, the number of participants reported here will be less than the total number of participants in the study. Severity is determined from the International Index of Erectile Function Scores. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30. Severity is determined based on scores as follows: Severe ED ≤10 Moderate ED 11-16 Mild ED 17-25 No ED >25
[3]	Severity was assessed through the International Prostate Symptom (IPSS) Total Score. The Total Score was obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for a range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
[4]	Body mass index is an estimate of body fat based on body weight divided by height squared.

Outcome Measures

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1. Primary:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score [ Time Frame: baseline, 12 weeks ]

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2. Secondary:

Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score [ Time Frame: baseline, 4 and 8 weeks ]

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3. Secondary:

Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore [ Time Frame: baseline, 4, 8, and 12 weeks ]

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4. Secondary:

Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore [ Time Frame: baseline, 4, 8, and 12 weeks ]

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5. Secondary:

Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore [ Time Frame: baseline, 4, 8, and 12 weeks ]

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6. Secondary:

Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) [ Time Frame: baseline, 12 weeks ]

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7. Secondary:

Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies [ Time Frame: 12 weeks ]

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8. Secondary:

Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies [ Time Frame: 12 weeks ]

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9. Secondary:

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 [ Time Frame: baseline, 12 weeks ]

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10. Secondary:

Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary [ Time Frame: baseline, 12 weeks ]

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11. Secondary:

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 [ Time Frame: baseline, 12 weeks ]

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12. Secondary:

Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) [ Time Frame: baseline, 12 weeks ]

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13. Secondary:

Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) [ Time Frame: baseline, 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00540124 History of Changes
Other Study ID Numbers:	11658, H6D-MC-LVHT
Study First Received:	October 3, 2007
Results First Received:	June 1, 2009
Last Updated:	November 18, 2010
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)