Trial Outcomes & Findings for A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes. (NCT NCT00734604)
NCT ID: NCT00734604
Last Updated: 2010-11-18
Results Overview
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
378 participants
Primary outcome timeframe
baseline, 8 weeks of each treatment
Results posted on
2010-11-18
Participant Flow
Participant milestones
| Measure |
T(OaD)/S(PRN)/T(PRN)
Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
|
T(OaD)/T(PRN)/S(PRN)
Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
|
S(PRN)/T(OaD)/T(PRN)
Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
|
S(PRN)/T(PRN)/T(OaD)
Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
|
T(PRN)/T(OaD)/S(PRN)
Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
|
T(PRN)/S(PRN)/T(OaD)
Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
63
|
63
|
63
|
64
|
|
Overall Study
COMPLETED
|
59
|
51
|
57
|
54
|
55
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
12
|
6
|
9
|
8
|
6
|
Reasons for withdrawal
| Measure |
T(OaD)/S(PRN)/T(PRN)
Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
|
T(OaD)/T(PRN)/S(PRN)
Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
|
S(PRN)/T(OaD)/T(PRN)
Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
|
S(PRN)/T(PRN)/T(OaD)
Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
|
T(PRN)/T(OaD)/S(PRN)
Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
|
T(PRN)/S(PRN)/T(OaD)
Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
2
|
1
|
1
|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
1
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
4
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
2
|
1
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
Baseline characteristics by cohort
| Measure |
T(OaD)/S(PRN)/T(PRN)
n=62 Participants
Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
|
T(OaD)/T(PRN)/S(PRN)
n=63 Participants
Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
|
S(PRN)/T(OaD)/T(PRN)
n=63 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks
|
S(PRN)/T(PRN)/T(OaD)
n=63 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
|
T(PRN)/T(OaD)/S(PRN)
n=63 Participants
Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks
|
T(PRN)/S(PRN)/T(OaD)
n=64 Participants
Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
58.53 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
55.12 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
55.40 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
54.87 years
STANDARD_DEVIATION 12.04 • n=4 Participants
|
59.04 years
STANDARD_DEVIATION 10.56 • n=21 Participants
|
54.36 years
STANDARD_DEVIATION 10.28 • n=8 Participants
|
56.21 years
STANDARD_DEVIATION 10.98 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
378 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
12 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
41 participants
n=5 Participants
|
44 participants
n=7 Participants
|
46 participants
n=5 Participants
|
41 participants
n=4 Participants
|
43 participants
n=21 Participants
|
40 participants
n=8 Participants
|
255 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
15 participants
n=5 Participants
|
18 participants
n=4 Participants
|
17 participants
n=21 Participants
|
19 participants
n=8 Participants
|
105 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
24 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
7 participants
n=8 Participants
|
40 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=8 Participants
|
29 participants
n=8 Participants
|
|
Region of Enrollment
Mexico
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
14 participants
n=4 Participants
|
14 participants
n=21 Participants
|
14 participants
n=8 Participants
|
84 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=8 Participants
|
57 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
44 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
16 participants
n=4 Participants
|
17 participants
n=21 Participants
|
17 participants
n=8 Participants
|
100 participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
28.35 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.18 • n=5 Participants
|
27.62 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 2.65 • n=7 Participants
|
27.77 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.71 • n=5 Participants
|
28.68 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.74 • n=4 Participants
|
27.80 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.51 • n=21 Participants
|
29.08 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.26 • n=8 Participants
|
28.22 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.91 • n=8 Participants
|
|
Erectile Dysfunction (ED) Duration
=> 1 year
|
59 participants
n=5 Participants
|
61 participants
n=7 Participants
|
58 participants
n=5 Participants
|
58 participants
n=4 Participants
|
61 participants
n=21 Participants
|
59 participants
n=8 Participants
|
356 participants
n=8 Participants
|
|
Erectile Dysfunction (ED) Duration
=> than 6 months through <1 year
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
5 participants
n=8 Participants
|
22 participants
n=8 Participants
|
|
ED Etiology
Mixed
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
21 participants
n=5 Participants
|
23 participants
n=4 Participants
|
23 participants
n=21 Participants
|
28 participants
n=8 Participants
|
146 participants
n=8 Participants
|
|
ED Etiology
Organic
|
22 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
29 participants
n=4 Participants
|
30 participants
n=21 Participants
|
25 participants
n=8 Participants
|
163 participants
n=8 Participants
|
|
ED Etiology
Psychogenic
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
1 participants
n=21 Participants
|
7 participants
n=8 Participants
|
34 participants
n=8 Participants
|
|
ED Etiology
Unknown
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
4 participants
n=8 Participants
|
35 participants
n=8 Participants
|
|
Prior sildenafil citrate use as needed (PRN)
Yes
|
36 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
39 participants
n=4 Participants
|
39 participants
n=21 Participants
|
35 participants
n=8 Participants
|
229 participants
n=8 Participants
|
|
Prior sildenafil citrate use as needed (PRN)
No
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
24 participants
n=4 Participants
|
24 participants
n=21 Participants
|
29 participants
n=8 Participants
|
149 participants
n=8 Participants
|
|
Prior Vardenafil HCl use
Yes
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
17 participants
n=5 Participants
|
10 participants
n=4 Participants
|
19 participants
n=21 Participants
|
19 participants
n=8 Participants
|
104 participants
n=8 Participants
|
|
Prior Vardenafil HCl use
No
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
46 participants
n=5 Participants
|
53 participants
n=4 Participants
|
44 participants
n=21 Participants
|
45 participants
n=8 Participants
|
274 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: baseline, 8 weeks of each treatmentThe PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=351 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=347 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
Baseline
|
2.24 units on a scale
Standard Deviation 0.62
|
2.23 units on a scale
Standard Deviation 0.63
|
—
|
|
Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
Change from Baseline
|
0.50 units on a scale
Standard Deviation 0.78 • Interval 0.41 to 0.57
|
0.39 units on a scale
Standard Deviation 0.67 • Interval 0.29 to 0.45
|
—
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentThe PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=351 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=354 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
Baseline
|
2.24 units on a scale
Standard Deviation 0.62
|
2.24 units on a scale
Standard Deviation 0.63
|
—
|
|
Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
Change from Baseline
|
0.50 units on a scale
Standard Deviation 0.78
|
0.50 units on a scale
Standard Deviation 0.72
|
—
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentThe PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=351 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=347 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=354 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
Baseline
|
3.06 units on a scale
Standard Deviation 0.48
|
3.07 units on a scale
Standard Deviation 0.48
|
3.07 units on a scale
Standard Deviation 0.48
|
|
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
Change from Baseline
|
0.10 units on a scale
Standard Deviation 0.50
|
-0.05 units on a scale
Standard Deviation 0.49
|
0.07 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentThe PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=351 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=347 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=354 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
Baseline
|
2.43 units on a scale
Standard Deviation 0.53
|
2.42 units on a scale
Standard Deviation 0.54
|
2.42 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
Change from Baseline
|
-0.30 units on a scale
Standard Deviation 0.03
|
0.00 units on a scale
Standard Deviation 0.53
|
-0.17 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentSelf-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=350 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
Baseline
|
15.60 units on a scale
Standard Deviation 6.26
|
15.40 units on a scale
Standard Deviation 6.27
|
15.55 units on a scale
Standard Deviation 6.23
|
|
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
Change from Baseline
|
8.68 units on a scale
Standard Deviation 6.94
|
9.70 units on a scale
Standard Deviation 7.01
|
9.54 units on a scale
Standard Deviation 7.00
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentOutcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=352 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=355 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=347 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Baseline
|
0.28 proportion of days
Standard Deviation 0.26
|
0.28 proportion of days
Standard Deviation 0.26
|
0.27 proportion of days
Standard Deviation 0.26
|
|
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Change from Baseline
|
0.26 proportion of days
Standard Deviation 0.29
|
0.20 proportion of days
Standard Deviation 0.25
|
0.11 proportion of days
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentSelf-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=350 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF
Change from Baseline
|
3.33 units on a scale
Standard Deviation 3.16
|
3.99 units on a scale
Standard Deviation 3.17
|
3.83 units on a scale
Standard Deviation 3.13
|
|
Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF
Baseline
|
8.35 units on a scale
Standard Deviation 2.76
|
8.34 units on a scale
Standard Deviation 2.77
|
8.37 units on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentSelf-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=350 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF
Baseline
|
5.26 units on a scale
Standard Deviation 2.34
|
5.22 units on a scale
Standard Deviation 2.36
|
5.27 units on a scale
Standard Deviation 2.34
|
|
Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF
Change from Baseline
|
2.60 units on a scale
Standard Deviation 2.61
|
2.87 units on a scale
Standard Deviation 2.55
|
2.84 units on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: 8 weeks of each treatmentEDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=351 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint
|
75.81 units on a scale
Standard Deviation 22.36
|
75.68 units on a scale
Standard Deviation 19.58
|
79.50 units on a scale
Standard Deviation 19.56
|
SECONDARY outcome
Timeframe: baseline through 26 weeks (including two washout periods of 1 week each)Serious adverse events are listed in the Reported Adverse Event module.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=378 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=378 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=378 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Number of Participants With at Least One Serious Adverse Event
|
4 participants
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline, 8 weeks of each treatmentMeasures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=348 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=347 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score
Baseline
|
50.28 units on a scale
Standard Deviation 21.36
|
50.50 units on a scale
Standard Deviation 21.58
|
50.69 units on a scale
Standard Deviation 21.32
|
|
Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score
Change from Baseline
|
22.94 units on a scale
Standard Deviation 24.86
|
22.87 units on a scale
Standard Deviation 24.43
|
24.13 units on a scale
Standard Deviation 24.53
|
SECONDARY outcome
Timeframe: 8 weeks of each treatmentScores for Question 1 range from 0 (not at all) to 4 (extremely).
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=349 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
|
1.83 units on a scale
Standard Deviation 1.25
|
1.78 units on a scale
Standard Deviation 1.13
|
1.77 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 8 weeks of each treatmentScores for Question 2 range from 0 (not at all) to 4 (extremely).
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=349 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
|
2.33 units on a scale
Standard Deviation 1.09
|
2.14 units on a scale
Standard Deviation 1.01
|
2.36 units on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 8 weeks of each treatmentScores for Question 3 range from 0 (not at all) to 4 (extremely).
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=349 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
|
1.99 units on a scale
Standard Deviation 1.19
|
2.28 units on a scale
Standard Deviation 1.12
|
2.50 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 8 weeks of each treatmentScores for Question 4 range from 0 (not at all) to 4 (extremely).
Outcome measures
| Measure |
Tadalafil Once a Day [T(OaD)]
n=349 Participants
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil as Needed [S(PRN)]
n=348 Participants
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=355 Participants
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
|
2.53 units on a scale
Standard Deviation 1.10
|
2.57 units on a scale
Standard Deviation 1.06
|
2.44 units on a scale
Standard Deviation 0.99
|
Adverse Events
Tadalafil Once a Day [T(OaD)]
Serious events: 4 serious events
Other events: 66 other events
Deaths: 0 deaths
Sildenafil Citrate as Needed [S(PRN)]
Serious events: 5 serious events
Other events: 73 other events
Deaths: 0 deaths
Tadalafil as Needed [T(PRN)]
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tadalafil Once a Day [T(OaD)]
n=378 participants at risk
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil Citrate as Needed [S(PRN)]
n=378 participants at risk
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=378 participants at risk
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Infections and infestations
Pneumonia
|
0.53%
2/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Surgical and medical procedures
Elbow operation
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
Other adverse events
| Measure |
Tadalafil Once a Day [T(OaD)]
n=378 participants at risk
Tadalafil 5 mg once a day \[T(OaD)\]
|
Sildenafil Citrate as Needed [S(PRN)]
n=378 participants at risk
Sildenafil citrate 100 mg as needed \[S(PRN)\]
|
Tadalafil as Needed [T(PRN)]
n=378 participants at risk
Tadalafil 20 mg as needed \[T(PRN)\]
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Cardiac disorders
Tachycardia
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.53%
2/378 • Number of events 2
|
0.53%
2/378 • Number of events 2
|
0.53%
2/378 • Number of events 2
|
|
Eye disorders
Abnormal sensation in eye
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/378
|
0.53%
2/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
|
Eye disorders
Cyanopsia
|
0.00%
0/378
|
0.53%
2/378 • Number of events 2
|
0.00%
0/378
|
|
Eye disorders
Eye disorder
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/378
|
0.26%
1/378 • Number of events 2
|
0.00%
0/378
|
|
Eye disorders
Photopsia
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Eye disorders
Visual brightness
|
0.00%
0/378
|
0.26%
1/378 • Number of events 10
|
0.00%
0/378
|
|
Eye disorders
Visual impairment
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.26%
1/378 • Number of events 1
|
0.53%
2/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.53%
2/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.53%
2/378 • Number of events 2
|
0.00%
0/378
|
0.00%
0/378
|
|
Gastrointestinal disorders
Anal pruritus
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
3/378 • Number of events 3
|
1.1%
4/378 • Number of events 6
|
0.53%
2/378 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
6/378 • Number of events 6
|
1.3%
5/378 • Number of events 15
|
1.1%
4/378 • Number of events 7
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.53%
2/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
0.53%
2/378 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.79%
3/378 • Number of events 3
|
0.79%
3/378 • Number of events 9
|
0.53%
2/378 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/378
|
0.00%
0/378
|
0.53%
2/378 • Number of events 2
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/378
|
0.26%
1/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/378
|
0.26%
1/378 • Number of events 10
|
0.00%
0/378
|
|
General disorders
Feeling hot
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.53%
2/378 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Immune system disorders
Food allergy
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Ear infection fungal
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Eye infection
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Infections and infestations
Fungal infection
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Infections and infestations
Influenza
|
0.26%
1/378 • Number of events 1
|
0.53%
2/378 • Number of events 2
|
0.53%
2/378 • Number of events 2
|
|
Infections and infestations
Lower respiratory tract infection
|
0.53%
2/378 • Number of events 2
|
0.79%
3/378 • Number of events 3
|
0.53%
2/378 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/378
|
0.79%
3/378 • Number of events 3
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Onychomycosis
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Infections and infestations
Otitis externa
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Pharyngotonsillitis
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Infections and infestations
Pneumonia bacterial
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Infections and infestations
Postoperative wound infection
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Infections and infestations
Rhinitis
|
0.53%
2/378 • Number of events 2
|
0.53%
2/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.00%
0/378
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.79%
3/378 • Number of events 3
|
0.26%
1/378 • Number of events 1
|
0.53%
2/378 • Number of events 2
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Investigations
Blood pressure increased
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/378
|
0.53%
2/378 • Number of events 2
|
0.53%
2/378 • Number of events 2
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
3/378 • Number of events 4
|
0.79%
3/378 • Number of events 3
|
1.3%
5/378 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/378
|
0.26%
1/378 • Number of events 2
|
0.00%
0/378
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
5/378 • Number of events 5
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/378
|
0.53%
2/378 • Number of events 19
|
0.00%
0/378
|
|
Nervous system disorders
Headache
|
2.6%
10/378 • Number of events 10
|
3.4%
13/378 • Number of events 20
|
2.1%
8/378 • Number of events 18
|
|
Nervous system disorders
Migraine
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Nervous system disorders
Nerve compression
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/378
|
0.26%
1/378 • Number of events 4
|
0.53%
2/378 • Number of events 2
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Reproductive system and breast disorders
Prostatitis
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
5/378 • Number of events 5
|
2.1%
8/378 • Number of events 15
|
0.79%
3/378 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.26%
1/378 • Number of events 1
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/378
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
0.26%
1/378 • Number of events 1
|
|
Surgical and medical procedures
Cataract operation
|
0.26%
1/378 • Number of events 2
|
0.26%
1/378 • Number of events 1
|
0.00%
0/378
|
|
Vascular disorders
Flushing
|
1.6%
6/378 • Number of events 6
|
2.1%
8/378 • Number of events 26
|
0.79%
3/378 • Number of events 3
|
|
Vascular disorders
Hot flush
|
0.00%
0/378
|
0.00%
0/378
|
0.53%
2/378 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.53%
2/378 • Number of events 2
|
0.53%
2/378 • Number of events 2
|
1.1%
4/378 • Number of events 4
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60