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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352507
First Posted: May 12, 2011
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
Results First Submitted: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Erectile Dysfunction
Interventions: Drug: Tadalafil
Drug: Sildenafil

  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
No text entered.

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.

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

Baseline Measures
   Tadalafil Then Sildenafil   Sildenafil Then Tadalafil   Total 
Overall Participants Analyzed 
[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) 
[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.
Erectile Dysfunction (ED) Severity [1] 
[Units: Participants]
 		     
Mild   63   68   131 
Moderate   68   65   133 
Severe   59   60   119 
[1] 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.
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 


  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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 6

7.  Secondary:   Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain   [ Time Frame: Baseline, Week 8, and Week 18 ]
  Show Outcome Measure 7

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

9.  Secondary:   Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain   [ Time Frame: Baseline, Week 8, and Week 18 ]
  Show Outcome Measure 9

10.  Secondary:   Change in Sexual Encounter Profile (SEP) Question 3   [ Time Frame: Baseline, Week 8, and Week 18 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 12

13.  Secondary:   Change in International Index of Erectile Function (IIEF) Erectile Function Domain   [ Time Frame: Baseline, Week 8, and Week 18 ]
  Show Outcome Measure 13


  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:
unchecked 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.
unchecked 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 )
First Submitted: May 10, 2011
First Posted: May 12, 2011
Results First Submitted: March 13, 2013
Results First Posted: April 26, 2013
Last Update Posted: April 26, 2013



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