Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00836693
First received: February 2, 2009
Last updated: December 15, 2010
Last verified: December 2010
Results First Received: December 15, 2010  
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: Erectile Dysfunction
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
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 Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.

Participant Flow:   Overall Study
    Tadalafil     Placebo  
STARTED     147     70  
COMPLETED     130     64  
NOT COMPLETED     17     6  
Adverse Event                 4                 1  
Sponsor Decision                 0                 1  
Physician Decision                 2                 0  
Withdrawal by Subject                 9                 4  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 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.
No text entered.

Reporting Groups
  Description
Tadalafil Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
Placebo Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Tadalafil     Placebo     Total  
Number of Participants  
[units: participants]
  147     70     217  
Age  
[units: years]
Mean ± Standard Deviation
  52.2  ± 10.90     51.9  ± 10.35     52.1  ± 10.71  
Gender  
[units: participants]
     
Female     0     0     0  
Male     147     70     217  
Race/Ethnicity, Customized  
[units: participants]
     
White     144     69     213  
Asian     2     0     2  
Unknown     1     1     2  
Region of Enrollment  
[units: participants]
     
Germany     39     19     58  
Greece     19     9     28  
Italy     27     13     40  
Poland     31     14     45  
Spain     31     15     46  
Body Mass Index (BMI)  
[units: kilograms per square meter (kg/m²)]
Mean ± Standard Deviation
  27.92  ± 4.685     27.74  ± 3.423     27.86  ± 4.313  



  Outcome Measures
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1.  Primary:   Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses   [ Time Frame: Baseline, Week 12 ]

3.  Primary:   Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses   [ Time Frame: Baseline, 12 weeks ]

4.  Secondary:   Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary   [ Time Frame: Baseline, 12 weeks ]

8.  Secondary:   The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint   [ Time Frame: Week 12 ]

9.  Secondary:   Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)   [ Time Frame: Baseline, Week 12 ]

11.  Secondary:   Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)   [ Time Frame: Baseline, 12 weeks ]

12.  Secondary:   Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)   [ Time Frame: Baseline, 12 weeks ]

14.  Secondary:   Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses   [ Time Frame: Baseline, 12 weeks ]

15.  Secondary:   Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses   [ Time Frame: Baseline, 12 weeks ]

16.  Secondary:   Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses   [ Time Frame: Baseline, 12 weeks ]

17.  Secondary:   Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint   [ Time Frame: Week 12 ]

18.  Secondary:   Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


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


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00836693     History of Changes
Other Study ID Numbers: 12229, H6D-MC-LVHX
Study First Received: February 2, 2009
Results First Received: December 15, 2010
Last Updated: December 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines