A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Erectile Dysfunction
Interventions:	Drug: Tadalafil Drug: Sildenafil

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
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Reporting Groups

	Description
Tadalafil Then Sildenafil	20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).
Sildenafil Then Tadalafil	100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.

Description

Tadalafil Then Sildenafil

20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.

At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).

Sildenafil Then Tadalafil

100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.

At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.

Participant Flow for 4 periods

Period 1: Treatment Period 1

	Tadalafil Then Sildenafil	Sildenafil Then Tadalafil
STARTED	190	193
Received Treatment	182	188
COMPLETED	176	184
NOT COMPLETED	14	9
Adverse Event	3	0
Lost to Follow-up	3	4
Withdrawal by Subject	7	5
Physician Decision	1	0

Period 2: Washout Period

	Tadalafil Then Sildenafil	Sildenafil Then Tadalafil
STARTED	176	184
COMPLETED	176	183
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Period 3: Treatment Period 2

	Tadalafil Then Sildenafil	Sildenafil Then Tadalafil
STARTED	176	183
Received Treatment	173	181
COMPLETED	170 ^[1]	180 ^[2]
NOT COMPLETED	6	3
Entry Criteria Not Met	1	0
Withdrawal by Subject	4	3
Lack of Efficacy	1	0

[1]	Six participants who completed Treatment Period 2 chose not to enter the Extension Phase.
[2]	Seven participants who completed Treatment Period 2 chose not to enter the Extension Phase.

Period 4: Extension Phase

	Tadalafil Then Sildenafil	Sildenafil Then Tadalafil
STARTED	164	173
COMPLETED	164	173
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups

	Description
Tadalafil Then Sildenafil	20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).
Sildenafil Then Tadalafil	100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.
Total	Total of all reporting groups

Description

Tadalafil Then Sildenafil

20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.

At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).

Sildenafil Then Tadalafil

100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.

At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.

Total

Total of all reporting groups

Baseline Measures

	Tadalafil Then Sildenafil	Sildenafil Then Tadalafil	Total
Number of Participants [units: participants]	190	193	383
Age [units: years] Mean (Standard Deviation)	39.20 (10.52)	40.66 (11.44)	39.94 (11.00)
Gender [units: participants]
Female	0	0	0
Male	190	193	383
Race/Ethnicity, Customized [units: participants]
Chinese	190	193	383
Region of Enrollment [units: participants]
China	190	193	383
International Index of Erectile Function (IIEF) Erectile Function (EF) Domain ^[1] [units: units on a scale] Mean (Standard Deviation)	13.77 (5.37)	14.19 (6.08)	13.98 (5.73)
Erectile Dysfunction (ED) Severity ^[2] [units: participants]
Mild	63	68	131
Moderate	68	65	133
Severe	59	60	119
ED Duration [units: participants]
≥3 months to <1 year	77	87	164
≥1 year	113	106	219
ED Etiology [units: participants]
Psychogenic	46	41	87
Organic	11	13	24
Mixed	133	139	272

[1]	IIEF-EF was the sum of Questions (Q)1 through 5 and Q15 of the IIEF. Q1 to Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF-EF domain scores ranged from 1 to 30. Higher scores represented better erectile function.
[2]	Investigator-reported severity of a participant's ED. ED was defined as a consistent change in the quality of erection adversely affecting participant satisfaction with sexual intercourse. Severity was based on investigator opinion.

Outcome Measures

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1. Primary:

Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the "Phosphodiesterase 5 Inhibitor Treatment Preference" Questionnaire (PITPQ) [ Time Frame: Week 18 ]

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2. Secondary:

Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ [ Time Frame: Week 18 ]

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3. Secondary:

Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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4. Secondary:

Change in Sexual Encounter Profile (SEP) Question 2 [ Time Frame: Baseline, Week 8, and Week 18 ]

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5. Secondary:

Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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6. Secondary:

Drug Attributes Questionnaire (DRAQ) at Week 18 [ Time Frame: Week 18 ]

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7. Secondary:

Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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8. Secondary:

Change in International Index of Erectile Function (IIEF) Sexual Desire Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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9. Secondary:

Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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10. Secondary:

Change in Sexual Encounter Profile (SEP) Question 3 [ Time Frame: Baseline, Week 8, and Week 18 ]

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11. Secondary:

Change in PAIRS Spontaneity Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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12. Secondary:

Change in PAIRS Time Concerns Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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13. Secondary:

Change in International Index of Erectile Function (IIEF) Erectile Function Domain [ Time Frame: Baseline, Week 8, and Week 18 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01352507 History of Changes
Other Study ID Numbers:	14035 H6D-CR-LVIZ ( Other Identifier: Eli Lilly and Company )
Study First Received:	May 10, 2011
Results First Received:	March 13, 2013
Last Updated:	March 13, 2013
Health Authority:	China: Food and Drug Administration