Trial Outcomes & Findings for Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life (NCT NCT00422734)
NCT ID: NCT00422734
Last Updated: 2009-06-10
Results Overview
Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
COMPLETED
PHASE3
342 participants
Baseline and 12 weeks
2009-06-10
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
264
|
|
Overall Study
COMPLETED
|
64
|
243
|
|
Overall Study
NOT COMPLETED
|
14
|
21
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
6
|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Partner Decision
|
0
|
3
|
Baseline Characteristics
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
Baseline characteristics by cohort
| Measure |
Placebo
n=78 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=264 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.82 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
54.42 years
STANDARD_DEVIATION 10.04 • n=7 Participants
|
54.29 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
41 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
107 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
19 participants
n=5 Participants
|
63 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=5 Participants
|
17 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
36 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Erectile Dysfunction History - Duration
>= 1 year
|
73 participants
n=5 Participants
|
240 participants
n=7 Participants
|
313 participants
n=5 Participants
|
|
Erectile Dysfunction History - Duration
>= 3 months and < 6 months
|
1 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Erectile Dysfunction History - Duration
>= 6 months and < 1 year
|
4 participants
n=5 Participants
|
16 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Erectile Dysfunction History - Etiology
Mixed
|
34 participants
n=5 Participants
|
114 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Erectile Dysfunction History - Etiology
Organic
|
29 participants
n=5 Participants
|
91 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Erectile Dysfunction History - Etiology
Psychogenic
|
12 participants
n=5 Participants
|
30 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Erectile Dysfunction History - Etiology
Unknown
|
3 participants
n=5 Participants
|
29 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity
Mild (17-30)
|
35 participants
n=5 Participants
|
123 participants
n=7 Participants
|
158.0 participants
n=5 Participants
|
|
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity
Moderate (11-16)
|
22 participants
n=5 Participants
|
71 participants
n=7 Participants
|
93.0 participants
n=5 Participants
|
|
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity
Severe (1-10)
|
20 participants
n=5 Participants
|
63 participants
n=7 Participants
|
83.0 participants
n=5 Participants
|
|
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity
Missing
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8.0 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
57 participants
n=5 Participants
|
188 participants
n=7 Participants
|
245 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
21 participants
n=5 Participants
|
69 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Race/Ethnicity
Native American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
International Index of Erectile Function (IIEF) - Erectile Function Domain
|
15.27 units on a scale
STANDARD_DEVIATION 6.49 • n=5 Participants
|
15.73 units on a scale
STANDARD_DEVIATION 6.13 • n=7 Participants
|
15.62 units on a scale
STANDARD_DEVIATION 6.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
|
0.49 units on a scale
Standard Error 0.781
|
8.03 units on a scale
Standard Error 0.449
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
SQoL - Subject (change from baseline)
|
12.59 units on a scale
Standard Error 2.866
|
39.37 units on a scale
Standard Error 1.651
|
|
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
SQoL-Partner (change from baseline) (n=70, n=238)
|
7.93 units on a scale
Standard Error 2.861
|
32.87 units on a scale
Standard Error 1.638
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: all randomized participants having both baseline and at least one post-baseline data measurement
The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=251 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
Question 2 change from baseline in percent "yes"
|
2.19 percent
Standard Error 2.833
|
28.80 percent
Standard Error 1.644
|
|
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
Question 3 change from baseline in percent "yes"
|
10.80 percent
Standard Error 3.767
|
46.46 percent
Standard Error 2.185
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
Self-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 |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response
|
0.09 units on a scale
Standard Error 0.356
|
2.74 units on a scale
Standard Error 0.205
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
Self-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 |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response
|
0.44 units on a scale
Standard Error 0.257
|
2.57 units on a scale
Standard Error 0.148
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: all randomized participants having post-baseline data measurement on this variable
The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
SLQQ - Subject (n=72, n=244)
|
51.58 units on a scale
Standard Error 2.246
|
75.04 units on a scale
Standard Error 1.293
|
|
Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
SLQQ - Partner (n=70, n=238)
|
55.25 units on a scale
Standard Error 2.115
|
73.42 units on a scale
Standard Error 1.214
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: all randomized participants having both baseline and at least one post-baseline data measurement
The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
Outcome measures
| Measure |
Placebo
n=74 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=251 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
Question 4 change from baseline in percent "Yes"
|
12.08 percent
Standard Error 3.936
|
50.05 percent
Standard Error 2.283
|
|
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
Question 5 change from baseline in percent "Yes"
|
11.47 percent
Standard Error 3.951
|
48.78 percent
Standard Error 2.292
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: all randomized participants having both baseline and at least one post-baseline data measurement
The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of "yes" responses to the question during the run-in period and postbaseline period, respectively.
Outcome measures
| Measure |
Placebo
n=73 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=250 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response
|
10.21 percent
Standard Error 3.595
|
43.16 percent
Standard Error 2.072
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Placebo
n=70 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=238 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response
|
-0.40 units on a scale
Standard Error 0.130
|
0.32 units on a scale
Standard Error 0.075
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: all randomized participants having post-baseline data measurement on this variable
Percent of subjects with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response
GAQ Question 2
|
22 percentage of subjects answering Yes
|
79 percentage of subjects answering Yes
|
|
Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response
GAQ Question 1
|
26 percentage of subjects answering Yes
|
81 percentage of subjects answering Yes
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: all randomized participants having post-baseline data measurement on this variable
Percent of Partners with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Outcome measures
| Measure |
Placebo
n=70 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=238 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response
GAQ Question 1
|
30 percentage of partners answering Yes
|
79 percentage of partners answering Yes
|
|
Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response
GAQ Question 2
|
24 percentage of partners answering Yes
|
76 percentage of partners answering Yes
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: all randomized participants having both baseline and at least one post-baseline data measurement
The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
Outcome measures
| Measure |
Placebo
n=73 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=250 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response
Question 1 change from baseline in percent "Yes"
|
1.25 percent
Standard Error 2.224
|
18.34 percent
Standard Error 1.270
|
|
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response
Question 2 change from baseline in percent "Yes"
|
6.97 percent
Standard Error 2.896
|
30.69 percent
Standard Error 1.662
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
Measures 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 |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
Total Score change from baseline
|
3.07 units on a scale
Standard Error 2.616
|
30.44 units on a scale
Standard Error 1.506
|
|
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
Sexual Relationship change from baseline
|
4.61 units on a scale
Standard Error 2.903
|
34.28 units on a scale
Standard Error 1.673
|
|
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
Confidence change from baseline
|
0.91 units on a scale
Standard Error 2.567
|
25.35 units on a scale
Standard Error 1.475
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
n=244 Participants
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales
Self-Esteem change from baseline
|
3.26 units on a scale
Standard Error 2.743
|
29.56 units on a scale
Standard Error 1.579
|
|
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales
Overall Relationship change from baseline
|
-4.04 units on a scale
Standard Error 2.792
|
16.97 units on a scale
Standard Error 1.603
|
Adverse Events
Placebo
Tadalafil
Serious adverse events
| Measure |
Placebo
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
Other adverse events
| Measure |
Placebo
Placebo tablet taken by mouth once a day for 12 weeks
|
Tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
|
|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Eye disorders
Blepharitis
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/78 • Number of events 1
|
1.9%
5/264 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/78
|
4.5%
12/264 • Number of events 13
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/78
|
0.76%
2/264 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/78
|
1.9%
5/264 • Number of events 5
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/78
|
1.1%
3/264 • Number of events 3
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/78 • Number of events 1
|
0.76%
2/264 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
General disorders
Discomfort
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
General disorders
Fatigue
|
2.6%
2/78 • Number of events 2
|
0.00%
0/264
|
|
General disorders
Oedema mucosal
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Infections and infestations
Gastroenteritis
|
3.8%
3/78 • Number of events 3
|
0.76%
2/264 • Number of events 3
|
|
Infections and infestations
Herpes simplex
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/78
|
0.76%
2/264 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/78
|
0.76%
2/264 • Number of events 2
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/78 • Number of events 1
|
1.1%
3/264 • Number of events 4
|
|
Infections and infestations
Rhinitis
|
0.00%
0/78
|
1.1%
3/264 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Infections and infestations
Tonsillitis
|
1.3%
1/78 • Number of events 1
|
1.1%
3/264 • Number of events 3
|
|
Infections and infestations
Tooth infection
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/78 • Number of events 2
|
1.9%
5/264 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
1/78 • Number of events 1
|
1.1%
3/264 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/78
|
1.5%
4/264 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/78
|
1.9%
5/264 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • Number of events 1
|
0.38%
1/264 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.8%
3/78 • Number of events 4
|
8.3%
22/264 • Number of events 26
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Reproductive system and breast disorders
Hypoaesthesia of genital male
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Reproductive system and breast disorders
Painful erection
|
0.00%
0/78
|
0.38%
1/264 • Number of events 2
|
|
Reproductive system and breast disorders
Testicular pain
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/78 • Number of events 1
|
0.38%
1/264 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/78
|
2.7%
7/264 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
1/78 • Number of events 1
|
0.38%
1/264 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Surgical and medical procedures
Dental prosthesis placement
|
0.00%
0/78
|
0.38%
1/264 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/78
|
0.76%
2/264 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/78
|
1.1%
3/264 • Number of events 3
|
|
Vascular disorders
Hypotension
|
1.3%
1/78 • Number of events 1
|
0.00%
0/264
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60