A Study of Tadalafil in Men With Benign Prostatic Hyperplasia - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Benign Prostatic Hyperplasia (BPH)
Interventions:	Drug: Tadalafil 5 mg Drug: Placebo tablet Drug: Tamsulosin Drug: Placebo capsule

Participant Flow

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
Period 1: Screening and 4-week washout of benign prostatic hyperplasia (BPH), overactive bladder (OAB), and/or erectile dysfunction (ED) treatments. Period 2: 4-week, single-blind, placebo lead-in to assess compliance and establish baseline levels. Period 3: Randomization to treatment (placebo, tadalafil 5 mg, or tamsulosin 0.4 mg for 12 weeks).

Reporting Groups

	Description
Placebo	Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
Tadalafil 5 mg	Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
Tamsulosin 0.4 mg	Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Participant Flow: Overall Study

	Placebo	Tadalafil 5 mg	Tamsulosin 0.4 mg
STARTED	172	171	168
COMPLETED	148	156	150
NOT COMPLETED	24	15	18
Adverse Event	2	2	1
Lack of Efficacy	3	0	0
Lost to Follow-up	3	0	2
Protocol Violation	8	5	8
Withdrawal by Subject	7	6	4
Entry criteria not met	0	2	2
Sponsor decision	1	0	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
Tadalafil 5 mg	Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
Tamsulosin 0.4 mg	Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Baseline Measures

	Placebo	Tadalafil 5 mg	Tamsulosin 0.4 mg	Total
Number of Participants [units: participants]	172	171	168	511
Age [units: years] Mean ± Standard Deviation	63.7 ± 8.65	63.5 ± 8.08	63.5 ± 7.76	63.6 ± 8.16
Gender [units: participants]
Female	0	0	0	0
Male	172	171	168	511
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	49	47	43	139
Not Hispanic or Latino	123	124	125	372
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	41	40	37	118
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	1	0	1
White	131	130	131	392
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0
Region of Enrollment [units: participants]
Australia	6	9	10	25
Austria	13	10	7	30
Belgium	5	6	7	18
France	9	9	12	30
Germany	56	50	56	162
Greece	8	4	7	19
Italy	18	26	15	59
Mexico	43	41	38	122
Netherlands	2	3	6	11
Poland	12	13	10	35
Body Mass Index (BMI) ^[1] [units: kilogram per square meter (kg/m^2)] Mean ± Standard Deviation	28.1 ± 4.09	27.1 ± 4.03	27.9 ± 3.73	27.7 ± 3.96
Lower Urinary Tract Symptom (LUTS) Severity ^[2] [units: participants]
Moderate (IPSS <20)	118	123	119	360
Severe (IPSS ≥20)	54	48	49	151
Peak Urine Flow Rate (Qmax) Category ^[3] [units: participants]
<10 mL/sec	79	92	105	276
10-15 mL/sec	69	63	53	185
>15 mL/sec	18	12	7	37
Postvoid Residual Volume (PRV) ^[4] [units: milliliter (mL)] Mean ± Standard Deviation	50.9 ± 51.14	54.6 ± 52.29	59.8 ± 57.99	55.1 ± 53.88
Prostate Specific Antigen (PSA) ^[5] [units: nanograms per milliliter (ng/mL)] Mean ± Standard Deviation	2.0 ± 1.69	2.1 ± 1.83	1.9 ± 1.57	2.0 ± 1.70
Erectile Dysfunction (ED) ^[6] [units: participants]
Yes	120	121	116	357
No	52	50	52	154
Erectile Dysfunction (ED) Severity ^[7] [units: participants]
Mild	36	38	33	107
Moderate	64	65	60	189
Severe	20	18	23	61
Erectile Dysfunction (ED) Duration ^[8] [units: participants]
<1 year	15	28	29	72
≥1 year	105	93	87	285
Sexually Active with a Female Partner [units: participants]
Yes	145	143	139	427
No	27	28	29	84
Expect to Remain Sexually Active ^[9] [units: participants]
Yes	145	142	139	426
No	0	1	0	1

[1]	BMI measured the participant's body weight divided by the square of his or her height.
[2]	The total International Prostate Symptom Score (IPSS) was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms.
[3]	Qmax is a uroflowmetry parameter used to measure peak urine flow rate with a standard calibrated flowmeter in milliliters per second (mL/sec) at Visit 3 (Week 0). Percentages were based on the prevoid number of randomized participants with valid uroflowmetry data (N=498 participants). The uroflowmetry assessment was considered valid and data were included in this summary only if total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and voided volume (V-Comp) was ≥125 mL.
[4]	PRV was determined by ultrasound at baseline (Visit 3) and endpoint (Visit 7). The urine volume is measured following complete bladder emptying by the participant.
[5]	PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate disorders, such as prostate cancer.
[6]	ED was defined as a consistent change in the quality of erection adversely affecting participant satisfaction with sexual intercourse.
[7]	ED was defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse. Severity was based on investigator opinion. The participant population included 357 randomized subjects with ED.
[8]	ED was defined as a consistent change in the quality of erection adversely affecting subject satisfaction with sexual intercourse. The participant population included 357 randomized subjects with ED.
[9]	The participant population was based on 427 randomized subjects who reported being sexually active with a female partner.

Outcome Measures

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1. Primary:

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks [ Time Frame: Baseline, 4 weeks ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks. [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week [ Time Frame: Baseline, 1 week ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks [ Time Frame: Baseline, 4 weeks ]

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9. Secondary:

Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

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10. Secondary:

Patient Global Impression of Improvement (PGI-I) at 12 Weeks [ Time Frame: 12 weeks ]

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11. Secondary:

Clinician Global Impression of Improvement (CGI-I) at 12 Weeks [ Time Frame: 12 weeks ]

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12. Secondary:

Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall [ Time Frame: 12 weeks ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 13

14. Secondary:

Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 14

15. Secondary:

Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 15

16. Secondary:

Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 16

17. Secondary:

Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]

Show Outcome Measure 17

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:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00970632 History of Changes
Other Study ID Numbers:	12932, H6D-MC-LVID
Study First Received:	September 1, 2009
Results First Received:	November 21, 2011
Last Updated:	November 21, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ethics Committee; Greece: National Organization of Medicines; Italy: Ministry of Health; Mexico: Federal Commission for Sanitary Risks Protection; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products