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

This study has been completed.

Study NCT00384930 Information provided by Eli Lilly and Company

First Received on October 3, 2006. Last Updated on August 26, 2009 History of Changes

Results First Received: October 17, 2008

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

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
Prior to randomization, participants had a 1-4 week Screening/Wash-out Period, followed by a 4 week Placebo Run-In Period. 1813 participants were screened with 755 screen failures, and 1058 participants randomized. The two participants who did not receive study drug were not included in the baseline demographics table.

Reporting Groups

	Description
Placebo	placebo tablet by mouth once a day for twelve weeks
2.5 mg Tadalafil	2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg Tadalafil	5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg Tadalafil	10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg Tadalafil	20 mg tadalafil tablet by mouth once a day for twelve weeks

Participant Flow: Overall Study

	Placebo	2.5 mg Tadalafil	5 mg Tadalafil	10 mg Tadalafil	20 mg Tadalafil
STARTED	212	209	212	216	209
Received Double-Blind Study Drug	211	208	212	216	209
COMPLETED	185	182	182	175	162
NOT COMPLETED	27	27	30	41	47
Adverse Event	5	4	12	11	14
Entry Criteria Not Met	2	6	7	8	4
Lack of Efficacy	1	1	2	1	2
Lost to Follow-up	5	3	0	4	6
Physician Decision	0	1	1	0	1
Protocol Violation	1	0	1	6	4
Sponsor Decision	3	4	0	5	0
Withdrawal by Subject	9	7	7	6	16
Didn't Receive Double-Blind Study Drug	1	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	placebo tablet by mouth once a day for twelve weeks
2.5 mg Tadalafil	2.5 mg tadalafil tablet by mouth once a day for twelve weeks
5 mg Tadalafil	5 mg tadalafil tablet by mouth once a day for twelve weeks
10 mg Tadalafil	10 mg tadalafil tablet by mouth once a day for twelve weeks
20 mg Tadalafil	20 mg tadalafil tablet by mouth once a day for twelve weeks

Baseline Measures

	Placebo	2.5 mg Tadalafil	5 mg Tadalafil	10 mg Tadalafil	20 mg Tadalafil	Total
Number of Participants [units: participants]	211	208	212	216	209	1056
Age [units: years] Mean ± Standard Deviation	61.75 ± 7.69	62.03 ± 8.42	61.95 ± 8.17	62.22 ± 7.20	62.55 ± 8.09	62.10 ± 7.91
Gender [units: participants]
Female	0	0	0	0	0	0
Male	211	208	212	216	209	1056
Region of Enrollment [units: participants]
Australia	4	5	5	6	4	24
Canada	12	5	9	13	6	45
France	13	12	9	15	11	60
Germany	29	35	39	28	33	164
Greece	8	9	12	11	10	50
Italy	15	10	5	9	9	48
Mexico	19	16	17	19	19	90
Spain	3	3	2	5	4	17
Sweden	4	2	5	4	5	20
United States	105	112	109	106	108	540
Baseline (Visit 3) Lower Urinary Tract Symptoms (LUTS) Severity ^[1] [units: participants]
Moderate (<20 units on a scale: IPSS)	137	139	141	143	141	701
Severe (>=20 units on a scale: IPSS)	74	69	71	72	68	354
Unknown	0	0	0	1	0	1
Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH) [units: participants]
< 6 months	0	0	0	1	0	1
6 months to 1 year	44	27	37	27	39	174
1 year to 3 years	62	64	63	81	70	340
> 3 years	105	117	112	107	100	541
Erectile Dysfunction [units: participants]
Yes	142	135	144	150	145	716
No	67	71	68	64	61	331
Unknown	1	2	0	2	3	8
Not Collected	1	0	0	0	0	1
Previous Therapy for Benign Prostatic Hyperplasia (BPH) [units: participants]
No	153	139	158	160	152	762
Yes	58	69	54	56	57	294
Race/Ethnicity [units: participants]
African	3	3	7	5	5	23
Caucasian	179	184	179	186	176	904
East Asian	0	1	1	0	0	2
Hispanic	29	20	25	24	25	123
West Asian	0	0	0	1	3	4
Severity of Erectile Dysfunction (ED) ^[2] [units: participants]
Mild	38	42	41	56	40	217
Moderate	82	75	82	72	79	390
Severe	22	18	21	22	26	109
Sexually Active [units: participants]
No	42	40	33	42	48	205
Yes	169	168	179	174	161	851
Sexually Active and Erectile Dysfunction (ED) [units: participants]
Sexually Active with ED	115	113	117	120	116	581
Sexually Active without ED	54	55	62	54	45	270
Not Sexually Active with ED	26	21	25	28	28	128
Not Sexually Active without ED	15	17	8	12	18	70
Sexual Activity and/or ED Status is Unknown	1	2	0	2	2	7

[1]	LUTS Severity was measured with the International Prostate Symptom Score (IPSS), which has a scoring range of 0 to 35. Total scores: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
[2]	Severity was determine only on participants with Erectile Dysfunction using scores on International Index of Erectile Function (IIEF) EF Domain (sum of the scores for Questions 1 through 5 and Question 15) with a range of 0 to 30. Normal EF (≥26), mild ED (17 to 25), moderate ED (11 to 16), and severe ED (1 to 10).

Outcome Measures

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1. Primary:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis [ Time Frame: Baseline and 12 weeks ]

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2. Primary:

Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis [ Time Frame: Baseline and 12 weeks ]

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3. Secondary:

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

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4. Secondary:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore [ Time Frame: 12 weeks ]

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5. Secondary:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) [ Time Frame: baseline and 12 weeks ]

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6. Secondary:

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: baseline and 12 weeks ]

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7. Secondary:

Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) [ Time Frame: baseline and 12 weeks ]

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8. Secondary:

Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) [ Time Frame: 12 weeks ]

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9. Secondary:

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow [ Time Frame: baseline and 12 weeks ]

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10. Secondary:

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain [ Time Frame: baseline and 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: 1-800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Broderick GA, Brock GB, Roehrborn CG, Watts SD, Elion-Mboussa A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology. 2010 Jun;75(6):1452-8. Epub 2010 Feb 16.

Porst H, McVary KT, Montorsi F, Sutherland P, Elion-Mboussa A, Wolka AM, Viktrup L. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009 Oct;56(4):727-35. Epub 2009 Apr 22.

Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008 Oct;180(4):1228-34. Epub 2008 Aug 22.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00384930 History of Changes
Other Study ID Numbers:	9797, H6D-MC-LVHG
Study First Received:	October 3, 2006
Results First Received:	October 17, 2008
Last Updated:	August 26, 2009
Health Authority:	United States: Food and Drug Administration