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

This study has been completed.

Sponsor:

Collaborator:

ICOS Corporation

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00386009

First received: October 9, 2006

Last updated: July 1, 2009

Last verified: July 2009

History of Changes

Results First Received: May 4, 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

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	20 mg tadalafil tablet taken by mouth once a day for 12 weeks

Participant Flow: Overall Study

	Placebo	Tadalafil
STARTED	101	99
COMPLETED	92	89
NOT COMPLETED	9	10
Adverse Event	0	2
Death	1	0
Entry Criteria Not Met	0	2
Lost to Follow-up	1	1
Protocol Violation	1	0
Sponsor Decision	1	1
Withdrawal by Subject	5	4

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	20 mg tadalafil tablet taken by mouth once a day for 12 weeks
Total	Total of all reporting groups

Baseline Measures

	Placebo	Tadalafil	Total
Number of Participants [units: participants]	101	99	200
Age [units: years] Mean ± Standard Deviation	59.03 ± 9.69	58.16 ± 8.82	58.60 ± 9.26
Gender [units: participants]
Female	0	0	0
Male	101	99	200
Region of Enrollment [units: participants]
United States	99	95	194
Canada	2	4	6
Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity ^[1] [units: participants]
Moderate (IPSS <20)	34	35	69
Severe (IPSS ≥20)	66	62	128
Missing Baseline Measure	1	2	3
Bladder Outlet Obstruction Index (BOOI) ^[2] [units: participants]
Obstructed (BOOI > 40)	33	34	67
Equivocal (BOOI 20-40)	35	34	69
Unobstructed (BOOI < 20)	33	31	64
Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS) [units: participants]
6 months to 1 year	13	12	25
1 year to 3 years	36	30	66
> 3 years	52	57	109
Erectile Dysfunction Severity ^[3] [units: participants]
Mild	20	22	42
Moderate	31	31	62
Severe	9	5	14
Presence of Erectile Dysfunction [units: participants]
Yes	60	58	118
No	41	41	82
Previous Alpha-Blocker Therapy [units: participants]
Yes	22	21	43
No	79	78	157
Previous Therapy for Benign Prostatic Hyperplasia [units: participants]
Yes	34	29	63
No	67	70	137
Race/Ethnicity [units: participants]
American Indian or Alaska Native	0	1	1
Asian	3	2	5
Black or African American	12	13	25
Hispanic or Latino	8	8	16
White	78	75	153
Body Mass Index (BMI) ^[4] [units: kilograms/square centimeters (kg/cm^2)] Mean ± Standard Deviation	29.44 ± 4.47	29.45 ± 4.93	29.45 ± 4.69
Body Weight [units: kilograms] Mean ± Standard Deviation	92.94 ± 16.55	93.90 ± 16.49	93.42 ± 16.49
Height [units: centimeters] Mean ± Standard Deviation	177.56 ± 8.07	178.58 ± 7.50	178.07 ± 7.79
Postvoid Residual Volume by Ultrasound [units: milliliters] Mean ± Standard Deviation	59.30 ± 60.87	45.65 ± 49.58	52.51 ± 55.82
Prostate Specific Antigen (PSA) [units: nanograms per milliliter] Mean ± Standard Deviation	1.60 ± 1.13	1.51 ± 1.14	1.55 ± 1.13

[1]	Severity was determined by the International Prostate Symptom Score (IPSS)Total. The IPSS is obtained by combining the scores of the responses to the 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.
[2]	BOOI, or bladder outlet obstruction index, which is derived from the equation: pdetQmax-2Qmax (where pdetQmax is detrusor pressure at peak urinary flow rate and Qmax is defined as the peak urine flow rate).
[3]	This measure is only for participants who have Erectile Dysfunction.
[4]	Body mass index is an estimate of body fat based on body weight divided by height squared.

Outcome Measures

Show All Outcome Measures

1. Primary:

Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 8

9. Secondary:

Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 13

14. Secondary:

Presence of Involuntary Detrusor Contractions During Bladder Filling [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 14

15. Secondary:

Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

17. Secondary:

Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests [ Time Frame: Baseline and 12 weeks ]

Show Outcome Measure 17

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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:	NCT00386009 History of Changes
Other Study ID Numbers:	11233, H6D-MC-LVHK
Study First Received:	October 9, 2006
Results First Received:	May 4, 2009
Last Updated:	July 1, 2009
Health Authority:	United States: Food and Drug Administration

To Top