A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

This study has been completed.

Study NCT00734604 Information provided by Eli Lilly and Company

First Received on August 12, 2008. Last Updated on October 21, 2010 History of Changes

Results First Received: September 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Erectile Dysfunction
Interventions:	Drug: tadalafil once a day [T(OaD)] Drug: sildenafil citrate as needed [S(PRN)] Drug: tadalafil as needed [T(PRN)]

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
T(OaD)/S(PRN)/T(PRN)	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
T(OaD)/T(PRN)/S(PRN)	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
S(PRN)/T(OaD)/T(PRN)	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
S(PRN)/T(PRN)/T(OaD)	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
T(PRN)/T(OaD)/S(PRN)	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
T(PRN)/S(PRN)/T(OaD)	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks

Participant Flow: Overall Study

	T(OaD)/S(PRN)/T(PRN)	T(OaD)/T(PRN)/S(PRN)	S(PRN)/T(OaD)/T(PRN)	S(PRN)/T(PRN)/T(OaD)	T(PRN)/T(OaD)/S(PRN)	T(PRN)/S(PRN)/T(OaD)
STARTED	62	63	63	63	63	64
COMPLETED	59	51	57	54	55	58
NOT COMPLETED	3	12	6	9	8	6
Adverse Event	0	2	0	2	1	1
Serious Adverse Event	1	0	1	2	0	1
Lost to Follow-up	1	2	2	4	2	3
Physician Decision	0	1	1	0	0	0
Protocol Violation	0	2	0	0	1	0
Sponsor Decision	1	2	1	0	2	0
Withdrawal by Subject	0	2	0	1	2	1
Lack of Efficacy	0	1	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
T(OaD)/S(PRN)/T(PRN)	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
T(OaD)/T(PRN)/S(PRN)	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
S(PRN)/T(OaD)/T(PRN)	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
S(PRN)/T(PRN)/T(OaD)	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
T(PRN)/T(OaD)/S(PRN)	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
T(PRN)/S(PRN)/T(OaD)	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks

Baseline Measures

	T(OaD)/S(PRN)/T(PRN)	T(OaD)/T(PRN)/S(PRN)	S(PRN)/T(OaD)/T(PRN)	S(PRN)/T(PRN)/T(OaD)	T(PRN)/T(OaD)/S(PRN)	T(PRN)/S(PRN)/T(OaD)	Total
Number of Participants [units: participants]	62	63	63	63	63	64	378
Age [units: years] Mean ± Standard Deviation	58.53 ± 11.62	55.12 ± 8.89	55.40 ± 11.70	54.87 ± 12.04	59.04 ± 10.56	54.36 ± 10.28	56.21 ± 10.98
Gender [units: participants]
Female	0	0	0	0	0	0	0
Male	62	63	63	63	63	64	378
Race/Ethnicity, Customized [units: participants]
African	1	1	1	4	3	2	12
Caucasian	41	44	46	41	43	40	255
East Asian	1	0	1	0	0	1	3
Hispanic	19	17	15	18	17	19	105
Native American	0	0	0	0	0	2	2
West Asian	0	1	0	0	0	0	1
Region of Enrollment [units: participants]
Australia	3	4	5	4	4	4	24
Germany	7	6	6	7	7	7	40
Italy	5	5	4	6	4	5	29
Mexico	14	14	14	14	14	14	84
Spain	10	10	10	9	9	9	57
United Kingdom	6	8	7	7	8	8	44
United States	17	16	17	16	17	17	100
Body Mass Index (BMI) ^[1] [units: kilograms per square meter (kg/m^2)] Mean ± Standard Deviation	28.35 ± 4.18	27.62 ± 2.65	27.77 ± 3.71	28.68 ± 4.74	27.80 ± 3.51	29.08 ± 4.26	28.22 ± 3.91
Erectile Dysfunction (ED) Duration [units: participants]
=> 1 year	59	61	58	58	61	59	356
=> than 6 months through <1 year	3	2	5	5	2	5	22
ED Etiology [units: participants]
Mixed	25	26	21	23	23	28	146
Organic	22	28	29	29	30	25	163
Psychogenic	5	3	9	9	1	7	34
Unknown	10	6	4	2	9	4	35
Prior sildenafil citrate use as needed (PRN) [units: participants]
Yes	36	40	40	39	39	35	229
No	26	23	23	24	24	29	149
Prior Vardenafil HCl use [units: participants]
Yes	21	18	17	10	19	19	104
No	41	45	46	53	44	45	274

[1]	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 Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) [ Time Frame: baseline, 8 weeks of each treatment ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) [ Time Frame: baseline, 8 weeks of each treatment ]

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3. Secondary:

Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS [ Time Frame: baseline, 8 weeks of each treatment ]

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4. Secondary:

Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS [ Time Frame: baseline, 8 weeks of each treatment ]

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5. Secondary:

Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) [ Time Frame: baseline, 8 weeks of each treatment ]

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6. Secondary:

Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection [ Time Frame: baseline, 8 weeks of each treatment ]

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7. Secondary:

Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF [ Time Frame: baseline, 8 weeks of each treatment ]

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8. Secondary:

Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF [ Time Frame: baseline, 8 weeks of each treatment ]

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9. Secondary:

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint [ Time Frame: 8 weeks of each treatment ]

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10. Secondary:

Number of Participants With at Least One Serious Adverse Event [ Time Frame: baseline through 26 weeks (including two washout periods of 1 week each) ]

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11. Secondary:

Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score [ Time Frame: baseline, 8 weeks of each treatment ]

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12. Secondary:

Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ]

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13. Secondary:

Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ]

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14. Secondary:

Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ]

Show Outcome Measure 14

15. Secondary:

Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ]

Show Outcome Measure 15

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:	NCT00734604 History of Changes
Other Study ID Numbers:	12313, H6D-CR-S024
Study First Received:	August 12, 2008
Results First Received:	September 20, 2010
Last Updated:	October 21, 2010
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Mexico: Federal Commission for Sanitary Risks Protection; Mexico: Ethics Committee; Mexico: Ministry of Health; Spain: Ethics Committee; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; United States: Food and Drug Administration