Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

This study has been completed.

Study NCT00422734 Information provided by Eli Lilly and Company

First Received on January 16, 2007. Last Updated on June 8, 2009 History of Changes

Results First Received: December 23, 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:	Impotence
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
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Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Participant Flow: Overall Study

	Placebo	Tadalafil
STARTED	78	264
COMPLETED	64	243
NOT COMPLETED	14	21
Physician Decision	1	1
Protocol Violation	1	6
Withdrawal by Subject	12	8
Adverse Event	0	3
Partner Decision	0	3

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Baseline Measures

	Placebo	Tadalafil	Total
Number of Participants [units: participants]	78	264	342
Age [units: years] Mean ± Standard Deviation	53.82 ± 10.72	54.42 ± 10.04	54.29 ± 10.18
Gender [units: participants]
Female	0	0	0
Male	78	264	342
Region of Enrollment [units: participants]
France	11	41	52
United States	29	107	136
Mexico	19	63	82
Austria	8	17	25
Germany	11	36	47
Erectile Dysfunction History - Duration [units: participants]
>= 1 year	73	240	313
>= 3 months and < 6 months	1	8	9
>= 6 months and < 1 year	4	16	20
Erectile Dysfunction History - Etiology [units: participants]
Mixed	34	114	148
Organic	29	91	120
Psychogenic	12	30	42
Unknown	3	29	32
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity [units: participants]
Mild (17-30)	35	123	158
Moderate (11-16)	22	71	93
Severe (1-10)	20	63	83
Missing	1	7	8
Race/Ethnicity [units: participants]
African	0	6	6
Caucasian	57	188	245
Hispanic	21	69	90
Native American	0	1	1
International Index of Erectile Function (IIEF) - Erectile Function Domain ^[1] [units: units on a scale] Mean ± Standard Deviation	15.27 ± 6.49	15.73 ± 6.13	15.62 ± 6.21

[1]	Self-reported erectile function over the past 4 weeks. 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.

Outcome Measures

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1. Primary:

Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) [ Time Frame: Baseline and 12 weeks ]

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2. Primary:

Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) [ Time Frame: Baseline and 12 weeks ]

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3. Primary:

Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). [ Time Frame: Baseline and 12 weeks ]

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4. Secondary:

Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response [ Time Frame: Baseline and 12 weeks ]

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5. Secondary:

Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response [ Time Frame: Baseline and 12 weeks ]

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6. Secondary:

Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain [ Time Frame: 12 weeks ]

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7. Secondary:

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response [ Time Frame: Baseline and 12 weeks ]

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8. Secondary:

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response [ Time Frame: Baseline and 12 weeks ]

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9. Secondary:

Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response [ Time Frame: Baseline and 12 weeks ]

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10. Secondary:

Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response [ Time Frame: 12 weeks ]

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11. Secondary:

Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response [ Time Frame: 12 weeks ]

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12. Secondary:

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response [ Time Frame: Baseline and 12 weeks ]

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13. Secondary:

Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Baseline and 12 weeks ]

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14. Secondary:

Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales [ 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

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00422734 History of Changes
Other Study ID Numbers:	9501, H6D-MC-LVGH
Study First Received:	January 16, 2007
Results First Received:	December 23, 2008
Last Updated:	June 8, 2009
Health Authority:	United States: Food and Drug Administration