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

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ClinicalTrials.gov Identifier: NCT01352507
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Enrollment 383
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tadalafil Then Sildenafil Sildenafil Then Tadalafil
Hide Arm/Group Description

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).

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.

Period Title: Treatment Period 1
Started 190 193
Received Treatment 182 188
Completed 176 184
Not Completed 14 9
Reason Not Completed
Adverse Event             3             0
Lost to Follow-up             3             4
Withdrawal by Subject             7             5
Physician Decision             1             0
Period Title: Washout Period
Started 176 184
Completed 176 183
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Treatment Period 2
Started 176 183
Received Treatment 173 181
Completed 170 [1] 180 [2]
Not Completed 6 3
Reason Not Completed
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 Title: Extension Phase
Started 164 173
Completed 164 173
Not Completed 0 0
Arm/Group Title Tadalafil Then Sildenafil Sildenafil Then Tadalafil Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 190 193 383
Hide Baseline Analysis Population Description
All randomized participants.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 193 participants 383 participants
39.20  (10.52) 40.66  (11.44) 39.94  (11.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 193 participants 383 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
190
 100.0%
193
 100.0%
383
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Chinese Number Analyzed 190 participants 193 participants 383 participants
190 193 383
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 190 participants 193 participants 383 participants
190 193 383
International Index of Erectile Function (IIEF) Erectile Function (EF) Domain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants 193 participants 383 participants
13.77  (5.37) 14.19  (6.08) 13.98  (5.73)
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants 193 participants 383 participants
Mild 63 68 131
Moderate 68 65 133
Severe 59 60 119
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants 193 participants 383 participants
≥3 months to <1 year 77 87 164
≥1 year 113 106 219
ED Etiology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants 193 participants 383 participants
Psychogenic 46 41 87
Organic 11 13 24
Mixed 133 139 272
1.Primary Outcome
Title Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the "Phosphodiesterase 5 Inhibitor Treatment Preference" Questionnaire (PITPQ)
Hide Description PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.
Arm/Group Title All Randomized Participants
Hide Arm/Group Description:
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
Overall Number of Participants Analyzed 350
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69.1
(64 to 74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Randomized Participants
Comments Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilson Score method
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ
Hide Description PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, "For the treatment preference you selected in Q1, what is your degree of preference?". Choices were moderate or strong.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
Participants who preferred tadalafil over sildenafil.
Participants who preferred sildenafil over tadalafil.
Overall Number of Participants Analyzed 242 108
Measure Type: Number
Unit of Measure: percentage of participants
Strong preference 38.0 34.3
Moderate preference 62.0 65.7
3.Secondary Outcome
Title Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain
Hide Description Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.74  (1.94) 3.71  (2.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.793
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) mean difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.11 to 0.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Sexual Encounter Profile (SEP) Question 2
Hide Description Participant-assessed diary that assessed the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score was determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Change in percentage of "yes" responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 post-baseline SEP measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 356 354
Mean (Standard Deviation)
Unit of Measure: percentage of "yes" responses
45.28  (42.03) 44.94  (41.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.988
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-1.35 to 1.37
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain
Hide Description PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.75  (0.65) 0.72  (0.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.01 to 0.08
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Drug Attributes Questionnaire (DRAQ) at Week 18
Hide Description DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
Participants who preferred tadalafil over sildenafil.
Participants who preferred sildenafil over tadalafil.
Overall Number of Participants Analyzed 242 108
Measure Type: Number
Unit of Measure: percentage of participants
Time between drug and first erection was short 10.3 35.2
Was able to get an erection long after having drug 55.0 11.1
Had erections the next morning 24.0 11.1
The firmness of erections 36.4 51.9
Was able to get an erection every time 37.6 56.5
Had few side effects 23.6 25.9
Partner preferred this treatment 10.7 7.4
7.Secondary Outcome
Title Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain
Hide Description Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.88  (3.02) 5.91  (3.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.861
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.22 to 0.19
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in International Index of Erectile Function (IIEF) Sexual Desire Domain
Hide Description Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.55  (2.11) 2.60  (2.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.19 to 0.09
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain
Hide Description Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.70  (2.82) 3.71  (2.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.18 to 0.16
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Sexual Encounter Profile (SEP) Question 3
Hide Description Participant-assessed diary that assessed the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?". The SEP Q3 score was determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Change in the percentage of "yes" responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 SEP post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 356 354
Mean (Standard Deviation)
Unit of Measure: percentage of "yes" responses
64.53  (38.37) 63.72  (37.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.391
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
-1.58 to 4.04
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in PAIRS Spontaneity Domain
Hide Description PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The spontaneity domain score was the average score for Items 3, 12, 13, 16, 17, 19, 21, 22, and 28. Spontaneity domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS spontaneity domain at Week 8 and Week 18 were averaged to produce an overall change in PAIRS spontaneity domain score. Higher scores were indicative of greater spontaneity.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.33  (0.53) 0.20  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.09 to 0.18
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in PAIRS Time Concerns Domain
Hide Description PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The time concerns domain score was the average score for Items 1, 2, 6, 7, 8, 20, 24, and 25. Time concern domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS time concerns at Week 8 and Week 18 were averaged to produce an overall change in PAIRS time concerns domain score. Higher scores were indicative of more time concerns.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.28  (0.54) -0.14  (0.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.19 to -0.09
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in International Index of Erectile Function (IIEF) Erectile Function Domain
Hide Description Self-reported erectile function over the past 4 weeks. IIEF erectile function was the sum of Q1 through Q5 and Q15 of the IIEF. Q1 through 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 erectile function domain scores ranged from 1 to 30. Change was defined as endpoint minus baseline domain score. Change in IIEF erectile function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF EF domain score. Higher scores were indicative of better erectile function.
Time Frame Baseline, Week 8, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Arm/Group Title Tadalafil Sildenafil
Hide Arm/Group Description:
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 355 354
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.03  (6.75) 11.86  (6.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tadalafil, Sildenafil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.364
Comments P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.20 to 0.55
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tadalafil (Treatment Periods) Sildenafil (Treatment Periods) Tadalafil (Extension Phase) Sildenafil (Extension Phase)
Hide Arm/Group Description 20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2. 100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2. Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
All-Cause Mortality
Tadalafil (Treatment Periods) Sildenafil (Treatment Periods) Tadalafil (Extension Phase) Sildenafil (Extension Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Tadalafil (Treatment Periods) Sildenafil (Treatment Periods) Tadalafil (Extension Phase) Sildenafil (Extension Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/363 (0.00%)      0/361 (0.00%)      0/231 (0.00%)      0/106 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tadalafil (Treatment Periods) Sildenafil (Treatment Periods) Tadalafil (Extension Phase) Sildenafil (Extension Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/363 (8.26%)      26/361 (7.20%)      7/231 (3.03%)      2/106 (1.89%)    
Cardiac disorders         
Palpitations  1  1/363 (0.28%)  1 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Ear and labyrinth disorders         
Deafness  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Vertigo  1  1/363 (0.28%)  1 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Eye disorders         
Eye pain  1  2/363 (0.55%)  2 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Eye swelling  1  3/363 (0.83%)  3 0/361 (0.00%)  0 1/231 (0.43%)  1 0/106 (0.00%)  0
Ocular hyperaemia  1  0/363 (0.00%)  0 2/361 (0.55%)  2 0/231 (0.00%)  0 0/106 (0.00%)  0
Vision blurred  1  1/363 (0.28%)  1 1/361 (0.28%)  1 1/231 (0.43%)  1 0/106 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  0/363 (0.00%)  0 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Abdominal distension  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Diarrhoea  1  0/363 (0.00%)  0 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Dyspepsia  1  1/363 (0.28%)  1 2/361 (0.55%)  2 0/231 (0.00%)  0 0/106 (0.00%)  0
Gastric haemorrhage  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Gastrooesophageal reflux disease  1  0/363 (0.00%)  0 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Nausea  1  1/363 (0.28%)  1 2/361 (0.55%)  3 1/231 (0.43%)  1 0/106 (0.00%)  0
General disorders         
Face oedema  1  1/363 (0.28%)  1 1/361 (0.28%)  1 0/231 (0.00%)  0 1/106 (0.94%)  1
Feeling hot  1  0/363 (0.00%)  0 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Pyrexia  1  0/363 (0.00%)  0 2/361 (0.55%)  2 0/231 (0.00%)  0 0/106 (0.00%)  0
Thirst  1  1/363 (0.28%)  1 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Aspartate aminotransferase increased  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Body temperature increased  1  0/363 (0.00%)  0 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Metabolism and nutrition disorders         
Diabetes mellitus  1  1/363 (0.28%)  1 1/361 (0.28%)  1 1/231 (0.43%)  1 0/106 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  2/363 (0.55%)  2 2/361 (0.55%)  2 0/231 (0.00%)  0 0/106 (0.00%)  0
Groin pain  1  1/363 (0.28%)  2 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Myalgia  1  0/363 (0.00%)  0 0/361 (0.00%)  0 1/231 (0.43%)  1 0/106 (0.00%)  0
Nervous system disorders         
Dizziness  1  6/363 (1.65%)  7 3/361 (0.83%)  3 2/231 (0.87%)  4 0/106 (0.00%)  0
Headache  1  10/363 (2.75%)  13 5/361 (1.39%)  5 2/231 (0.87%)  4 0/106 (0.00%)  0
Psychiatric disorders         
Abnormal dreams  1  0/363 (0.00%)  0 0/361 (0.00%)  0 1/231 (0.43%)  1 0/106 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/363 (0.28%)  1 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Nasal congestion  1  3/363 (0.83%)  4 3/361 (0.83%)  3 1/231 (0.43%)  1 0/106 (0.00%)  0
Nasal obstruction  1  1/363 (0.28%)  1 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Rhinorrhoea  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Vascular disorders         
Flushing  1  2/363 (0.55%)  2 6/361 (1.66%)  7 0/231 (0.00%)  0 1/106 (0.94%)  1
Hypertension  1  1/363 (0.28%)  1 0/361 (0.00%)  0 0/231 (0.00%)  0 0/106 (0.00%)  0
Varicose vein  1  0/363 (0.00%)  0 1/361 (0.28%)  1 0/231 (0.00%)  0 0/106 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01352507    
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