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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01352507
First received: May 10, 2011
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: March 13, 2013  
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
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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
No text entered.

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  
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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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


No publications provided


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