Trial Outcomes & Findings for A Study of LY900010 in Erectile Dysfunction (NCT NCT01160289)
NCT ID: NCT01160289
Last Updated: 2019-04-09
Results Overview
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
410 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2019-04-09
Participant Flow
The study had 2 periods. Period 1: a screening, a 4-week washout, and a 4-week lead-in period prior to randomization. Period 2: a 12-week treatment and a 4-week follow-up period, post-randomization.
Participant milestones
| Measure |
All Screened Subjects
After screening but prior to randomization, subjects completed a 4-week washout and a 4-week tadalafil \[5-milligram (mg) tablet, administered orally, once daily\] lead-in period.
|
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
|
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
|
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
|
|---|---|---|---|---|---|---|
|
Screening, Washout, and Lead-In Period
STARTED
|
894
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
COMPLETED
|
410
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
NOT COMPLETED
|
484
|
0
|
0
|
0
|
0
|
0
|
|
Post-Randomization Period
STARTED
|
0
|
85
|
97
|
52
|
89
|
87
|
|
Post-Randomization Period
Received at Least 1 Dose of Study Drug
|
0
|
85
|
97
|
52
|
89
|
87
|
|
Post-Randomization Period
COMPLETED
|
0
|
65
|
73
|
31
|
80
|
73
|
|
Post-Randomization Period
NOT COMPLETED
|
0
|
20
|
24
|
21
|
9
|
14
|
Reasons for withdrawal
| Measure |
All Screened Subjects
After screening but prior to randomization, subjects completed a 4-week washout and a 4-week tadalafil \[5-milligram (mg) tablet, administered orally, once daily\] lead-in period.
|
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
|
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
|
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
|
|---|---|---|---|---|---|---|
|
Screening, Washout, and Lead-In Period
Adverse Event
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Entry Criteria Not Met
|
308
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Lost to Follow-up
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Physician Decision
|
26
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Randomization Criteria Not Met
|
67
|
0
|
0
|
0
|
0
|
0
|
|
Screening, Washout, and Lead-In Period
Withdrawal by Subject
|
64
|
0
|
0
|
0
|
0
|
0
|
|
Post-Randomization Period
Adverse Event
|
0
|
4
|
4
|
2
|
0
|
0
|
|
Post-Randomization Period
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Post-Randomization Period
Lack of Efficacy
|
0
|
1
|
0
|
3
|
0
|
0
|
|
Post-Randomization Period
Lost to Follow-up
|
0
|
3
|
2
|
5
|
3
|
4
|
|
Post-Randomization Period
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Post-Randomization Period
Protocol Violation
|
0
|
4
|
2
|
0
|
1
|
3
|
|
Post-Randomization Period
Withdrawal by Subject
|
0
|
5
|
13
|
8
|
5
|
7
|
|
Post-Randomization Period
Entry Criteria Not Met
|
0
|
2
|
2
|
2
|
0
|
0
|
|
Post-Randomization Period
Sponsor Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY900010 in Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=85 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=97 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=52 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=89 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=87 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 6.57 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 6.53 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 6.54 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 6.68 • n=21 Participants
|
59.9 years
STANDARD_DEVIATION 6.59 • 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
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
410 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
362 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
339 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
85 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
410 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug \[intention-to-treat (ITT) population\] and had non-missing IIEF EF domain scores at baseline and at Week 12; Last observation carried forward (LOCF) applied to statistical analyses.
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=66 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=74 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=34 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=83 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=74 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
|
2.515 units on a scale
Standard Deviation 6.019 • Interval 0.75 to 3.28
|
2.405 units on a scale
Standard Deviation 6.920 • Interval 0.88 to 3.27
|
-0.971 units on a scale
Standard Deviation 6.699 • Interval 0.7 to 3.27
|
3.530 units on a scale
Standard Deviation 5.640
|
2.054 units on a scale
Standard Deviation 4.800 • Interval 0.7 to 3.27
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing SEP diary data at baseline and at a post-baseline visit.
The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value \<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=79 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=86 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=46 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=80 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Question 1
|
-0.247 percentage of "yes" responses
Standard Error 2.378
|
-2.976 percentage of "yes" responses
Standard Error 2.295
|
-10.711 percentage of "yes" responses
Standard Error 3.268
|
4.427 percentage of "yes" responses
Standard Error 2.168
|
-1.425 percentage of "yes" responses
Standard Error 2.305
|
|
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Question 2
|
3.175 percentage of "yes" responses
Standard Error 3.345
|
3.689 percentage of "yes" responses
Standard Error 3.227
|
-7.849 percentage of "yes" responses
Standard Error 4.566
|
10.267 percentage of "yes" responses
Standard Error 3.064
|
1.844 percentage of "yes" responses
Standard Error 3.240
|
|
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Question 3
|
9.296 percentage of "yes" responses
Standard Error 3.808
|
11.752 percentage of "yes" responses
Standard Error 3.675
|
-3.800 percentage of "yes" responses
Standard Error 5.195
|
14.645 percentage of "yes" responses
Standard Error 3.489
|
2.593 percentage of "yes" responses
Standard Error 3.688
|
|
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Question 4
|
12.935 percentage of "yes" responses
Standard Error 3.998
|
13.910 percentage of "yes" responses
Standard Error 3.854
|
-1.570 percentage of "yes" responses
Standard Error 5.454
|
24.202 percentage of "yes" responses
Standard Error 3.656
|
8.857 percentage of "yes" responses
Standard Error 3.872
|
|
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Question 5
|
13.602 percentage of "yes" responses
Standard Error 4.027
|
15.196 percentage of "yes" responses
Standard Error 3.880
|
-1.956 percentage of "yes" responses
Standard Error 5.488
|
22.410 percentage of "yes" responses
Standard Error 3.683
|
9.400 percentage of "yes" responses
Standard Error 3.897
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF domain scores at baseline and at a post-baseline visit.
Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=80 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=48 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=81 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Intercourse Satisfaction
|
0.475 units on a scale
Standard Error 0.340
|
0.514 units on a scale
Standard Error 0.322
|
-0.672 units on a scale
Standard Error 0.463
|
1.127 units on a scale
Standard Error 0.310
|
0.554 units on a scale
Standard Error 0.327
|
|
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Orgasmic Function
|
0.510 units on a scale
Standard Error 0.289
|
0.117 units on a scale
Standard Error 0.274
|
0.160 units on a scale
Standard Error 0.394
|
0.678 units on a scale
Standard Error 0.264
|
0.733 units on a scale
Standard Error 0.278
|
|
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Sexual Desire
|
0.092 units on a scale
Standard Error 0.186
|
0.001 units on a scale
Standard Error 0.176
|
-0.201 units on a scale
Standard Error 0.253
|
0.392 units on a scale
Standard Error 0.169
|
0.180 units on a scale
Standard Error 0.178
|
|
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Overall Satisfaction
|
0.477 units on a scale
Standard Error 0.247
|
0.258 units on a scale
Standard Error 0.235
|
-0.378 units on a scale
Standard Error 0.339
|
1.206 units on a scale
Standard Error 0.226
|
0.826 units on a scale
Standard Error 0.238
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population).
The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to \>25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=85 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=97 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=52 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=89 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=87 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)
|
24.7 percentage of participants
|
27.8 percentage of participants
|
13.5 percentage of participants
|
30.3 percentage of participants
|
27.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF EF domain scores at baseline and at a post-baseline visit; Last observation carried forward (LOCF).
The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (\<340 nanograms per deciliter \[ng/dL\] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline\*treatment interaction (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=80 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=48 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=81 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
Testosterone <340 ng/dL
|
2.523 units on a scale
Standard Error 0.952
|
1.012 units on a scale
Standard Error 0.848
|
-1.055 units on a scale
Standard Error 1.223
|
4.172 units on a scale
Standard Error 0.852
|
1.935 units on a scale
Standard Error 0.912
|
|
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
Testosterone ≥340 ng/dL
|
1.077 units on a scale
Standard Error 1.019
|
3.416 units on a scale
Standard Error 1.071
|
-0.714 units on a scale
Standard Error 1.387
|
2.217 units on a scale
Standard Error 1.070
|
1.703 units on a scale
Standard Error 1.063
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing PSA data at baseline and at a post-baseline visit.
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=81 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=89 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=49 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=87 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=82 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
|
0.162 nanograms per milliliter (ng/mL)
Standard Error 0.119
|
-0.088 nanograms per milliliter (ng/mL)
Standard Error 0.109
|
0.265 nanograms per milliliter (ng/mL)
Standard Error 0.157
|
0.246 nanograms per milliliter (ng/mL)
Standard Error 0.107
|
0.032 nanograms per milliliter (ng/mL)
Standard Error 0.111
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (total cholesterol and triglycerides) at baseline and at a post-baseline visit.
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=81 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=90 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=49 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=82 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
Total Cholesterol
|
-0.210 millimoles per Liter (mmol/L)
Standard Error 0.076
|
-0.275 millimoles per Liter (mmol/L)
Standard Error 0.071
|
-0.282 millimoles per Liter (mmol/L)
Standard Error 0.102
|
-0.086 millimoles per Liter (mmol/L)
Standard Error 0.069
|
-0.059 millimoles per Liter (mmol/L)
Standard Error 0.072
|
|
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
Triglycerides
|
-0.155 millimoles per Liter (mmol/L)
Standard Error 0.070
|
-0.171 millimoles per Liter (mmol/L)
Standard Error 0.066
|
-0.067 millimoles per Liter (mmol/L)
Standard Error 0.096
|
-0.139 millimoles per Liter (mmol/L)
Standard Error 0.063
|
0.056 millimoles per Liter (mmol/L)
Standard Error 0.067
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (HDL-C and LDL-C) at baseline and at a post-baseline visit.
The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=81 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=90 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=49 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=82 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
HDL-C
|
-7.440 percent change
Standard Error 1.658
|
-16.974 percent change
Standard Error 1.556
|
-22.230 percent change
Standard Error 2.243
|
1.776 percent change
Standard Error 1.505
|
1.573 percent change
Standard Error 1.585
|
|
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
LDL-C
|
-1.695 percent change
Standard Error 2.479
|
0.062 percent change
Standard Error 2.319
|
-3.424 percent change
Standard Error 3.365
|
-0.066 percent change
Standard Error 2.245
|
-0.718 percent change
Standard Error 2.367
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting glucose) at baseline and at a post-baseline visit.
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=81 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=90 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=49 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=82 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Glucose
|
0.153 millimoles per Liter (mmol/L)
Standard Error 0.195
|
-0.306 millimoles per Liter (mmol/L)
Standard Error 0.183
|
0.070 millimoles per Liter (mmol/L)
Standard Error 0.268
|
-0.234 millimoles per Liter (mmol/L)
Standard Error 0.176
|
0.158 millimoles per Liter (mmol/L)
Standard Error 0.186
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting insulin) at baseline and at a post-baseline visit.
Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Outcome measures
| Measure |
1 mg LY2452473 and 5 mg Tadalafil
n=80 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473 and 5 mg Tadalafil
n=90 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg LY2452473
n=49 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
10 mg Tadalafil
n=88 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
5 mg Tadalafil
n=82 Participants
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
|
|---|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Insulin
|
3.756 milliunits per Liter (mU/L)
Standard Error 2.235
|
-4.501 milliunits per Liter (mU/L)
Standard Error 2.075
|
-0.717 milliunits per Liter (mU/L)
Standard Error 3.068
|
-3.300 milliunits per Liter (mU/L)
Standard Error 1.976
|
-1.276 milliunits per Liter (mU/L)
Standard Error 2.109
|
Adverse Events
5 mg Tadalafil, Lead-in Period
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
1 mg LY2452473 and 5 mg Tadalafil
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
5 mg LY2452473 and 5 mg Tadalafil
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
5 mg LY2452473
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
10 mg Tadalafil
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
5 mg Tadalafil
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Tadalafil, Lead-in Period
n=531 participants at risk
5-mg tadalafil tablet, administered orally, once daily, during the 4-week lead-in period.
|
1 mg LY2452473 and 5 mg Tadalafil
n=85 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473 and 5 mg Tadalafil
n=97 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473
n=52 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
|
10 mg Tadalafil
n=89 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
|
5 mg Tadalafil
n=87 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
0.00%
0/87
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
Other adverse events
| Measure |
5 mg Tadalafil, Lead-in Period
n=531 participants at risk
5-mg tadalafil tablet, administered orally, once daily, during the 4-week lead-in period.
|
1 mg LY2452473 and 5 mg Tadalafil
n=85 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473 and 5 mg Tadalafil
n=97 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
|
5 mg LY2452473
n=52 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
|
10 mg Tadalafil
n=89 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
|
5 mg Tadalafil
n=87 participants at risk
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Eye disorders
Corneal erosion
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Eye disorders
Eye swelling
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Eye disorders
Vision blurred
|
0.38%
2/531 • Number of events 2
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Gastrointestinal disorders
Constipation
|
0.56%
3/531 • Number of events 3
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Gastrointestinal disorders
Diarrhoea
|
0.75%
4/531 • Number of events 4
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
6/531 • Number of events 6
|
1.2%
1/85 • Number of events 1
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
1.1%
1/87 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
7/531 • Number of events 7
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
3.4%
3/89 • Number of events 3
|
2.3%
2/87 • Number of events 2
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Gastrointestinal disorders
Nausea
|
0.38%
2/531 • Number of events 2
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
General disorders
Chest discomfort
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
General disorders
Fatigue
|
0.75%
4/531 • Number of events 4
|
0.00%
0/85
|
2.1%
2/97 • Number of events 2
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
1.1%
1/87 • Number of events 1
|
|
General disorders
Irritability
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
General disorders
Oedema peripheral
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
General disorders
Pyrexia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Candidiasis
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Ear infection
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
0.00%
0/87
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Infections and infestations
Influenza
|
0.19%
1/531 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Infections and infestations
Nail infection
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.94%
5/531 • Number of events 5
|
3.5%
3/85 • Number of events 3
|
1.0%
1/97 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Oral herpes
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 2
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Infections and infestations
Pneumonia
|
0.00%
0/531
|
2.4%
2/85 • Number of events 2
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Rhinitis
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
1.1%
1/87 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Tinea infection
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
0.00%
0/87
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.38%
2/531 • Number of events 2
|
1.2%
1/85 • Number of events 1
|
2.1%
2/97 • Number of events 2
|
0.00%
0/52
|
4.5%
4/89 • Number of events 4
|
3.4%
3/87 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
3.8%
2/52 • Number of events 2
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 2
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.38%
2/531 • Number of events 2
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
2.3%
2/87 • Number of events 2
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
2.2%
2/89 • Number of events 2
|
1.1%
1/87 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
2.3%
2/87 • Number of events 2
|
|
Investigations
Blood creatine phosphokinase abnormal
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Blood creatine phosphokinase increased
|
0.38%
2/531 • Number of events 2
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
2.3%
2/87 • Number of events 2
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
0.00%
0/87
|
|
Investigations
Blood glucose increased
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Blood insulin increased
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Blood testosterone abnormal
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Blood urea abnormal
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Investigations
C-reactive protein increased
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Colonoscopy
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Investigations
Electrocardiogram qrs complex prolonged
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Oestradiol increased
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Investigations
Prostatic specific antigen increased
|
0.19%
1/531 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Investigations
Qrs axis abnormal
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Investigations
Weight decreased
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Investigations
Weight increased
|
0.19%
1/531 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.19%
1/531 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
2.1%
2/97 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
3.4%
3/89 • Number of events 3
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
4/531 • Number of events 4
|
3.5%
3/85 • Number of events 3
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
3.4%
3/89 • Number of events 3
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.56%
3/531 • Number of events 3
|
2.4%
2/85 • Number of events 3
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.56%
3/531 • Number of events 4
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
2.3%
2/87 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
2.3%
2/87 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.75%
4/531 • Number of events 4
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.56%
3/531 • Number of events 3
|
2.4%
2/85 • Number of events 3
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
0.00%
0/87
|
|
Nervous system disorders
Headache
|
1.7%
9/531 • Number of events 9
|
3.5%
3/85 • Number of events 3
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
3.4%
3/89 • Number of events 3
|
2.3%
2/87 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Nervous system disorders
Lethargy
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
0.00%
0/89
|
0.00%
0/87
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.38%
2/531 • Number of events 2
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
2.3%
2/87 • Number of events 2
|
|
Reproductive system and breast disorders
Prostatitis
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.56%
3/531 • Number of events 3
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
2.3%
2/87 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.38%
2/531 • Number of events 2
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.19%
1/531 • Number of events 1
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
1.9%
1/52 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/531
|
0.00%
0/85
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Skin and subcutaneous tissue disorders
Diabetic bullosis
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/531
|
0.00%
0/85
|
2.1%
2/97 • Number of events 2
|
0.00%
0/52
|
2.2%
2/89 • Number of events 2
|
0.00%
0/87
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.19%
1/531 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
0.00%
0/87
|
|
Vascular disorders
Flushing
|
0.19%
1/531 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
1.0%
1/97 • Number of events 1
|
0.00%
0/52
|
1.1%
1/89 • Number of events 1
|
1.1%
1/87 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/531
|
1.2%
1/85 • Number of events 1
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
0.00%
0/87
|
|
Vascular disorders
Hypotension
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
|
Vascular disorders
Spider vein
|
0.00%
0/531
|
0.00%
0/85
|
0.00%
0/97
|
0.00%
0/52
|
0.00%
0/89
|
1.1%
1/87 • Number of events 1
|
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