Trial Outcomes & Findings for A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels (NCT NCT01419236)
NCT ID: NCT01419236
Last Updated: 2014-12-19
Results Overview
MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed-effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level \[≥200 nanograms per deciliter (ng/dL) versus (vs.) \<200 ng/dL\], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.
COMPLETED
PHASE2
76 participants
Baseline, 16 weeks
2014-12-19
Participant Flow
Participant milestones
| Measure |
Testosterone Solution 2%
Testosterone solution 2% \[60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day\] for 16 weeks.
|
Placebo
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
40
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
35
|
39
|
|
Overall Study
COMPLETED
|
31
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Testosterone Solution 2%
Testosterone solution 2% \[60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day\] for 16 weeks.
|
Placebo
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Entry Criteria Not Met
|
1
|
0
|
Baseline Characteristics
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Baseline characteristics by cohort
| Measure |
Testosterone Solution 2%
n=36 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=40 Participants
Placebo solution applied topically once daily for 16 weeks.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 9.34 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 9.76 • 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
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed-effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level \[≥200 nanograms per deciliter (ng/dL) versus (vs.) \<200 ng/dL\], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks
|
3.61 units on a scale
Standard Error 0.88
|
2.95 units on a scale
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Ejaculate Volume at 16 Weeks
|
-0.12 mL
Standard Error 0.23
|
0.32 mL
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks
|
1.85 units on a scale
Standard Error 0.31
|
1.43 units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks
|
2.28 units on a scale
Standard Error 0.32
|
1.47 units on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks
|
1.68 units on a scale
Standard Error 0.34
|
1.38 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline, up to 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline; Last observation carried forward (LOCF).
The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks
|
0.89 sexual attempts
Standard Error 0.53
|
-0.14 sexual attempts
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks
|
1.37 units on a scale
Standard Error 0.31
|
1.05 units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks
|
1.21 units on a scale
Standard Error 0.42
|
1.29 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.
The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: "If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this?" Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. \<200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation.
Outcome measures
| Measure |
Testosterone Solution 2%
n=35 Participants
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=38 Participants
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks
|
-1.65 units on a scale
Standard Error 0.39
|
-1.62 units on a scale
Standard Error 0.36
|
Adverse Events
Testosterone Solution 2%
Placebo
Serious adverse events
| Measure |
Testosterone Solution 2%
n=36 participants at risk
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=40 participants at risk
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Testosterone Solution 2%
n=36 participants at risk
Testosterone solution 2% \[60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day\] for 16 weeks.
|
Placebo
n=40 participants at risk
Placebo solution applied topically once daily for 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • Number of events 1
|
7.5%
3/40 • Number of events 3
|
|
General disorders
Application site erythema
|
2.8%
1/36 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Application site pain
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Application site paraesthesia
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Application site pruritus
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Fatigue
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Axillary candidiasis
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Body tinea
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Scar
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Blood creatine phosphokinase increased
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Blood pressure increased
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Haematocrit increased
|
8.3%
3/36 • Number of events 3
|
0.00%
0/40
|
|
Investigations
Haemoglobin increased
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Heart rate increased
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • Number of events 2
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
2/36 • Number of events 2
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Number of events 2
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
0.00%
0/36
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Migraine
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
5.6%
2/36 • Number of events 2
|
0.00%
0/40
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Irritability
|
2.8%
1/36 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Libido increased
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Psychiatric disorders
Mood swings
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Reproductive system and breast disorders
Gynaecomastia
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Testicular hypertrophy
|
2.8%
1/36 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/36
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
2/36 • Number of events 2
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
2/36 • Number of events 2
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/36
|
5.0%
2/40 • Number of events 2
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/36
|
2.5%
1/40 • Number of events 2
|
|
Vascular disorders
Hot flush
|
0.00%
0/36
|
2.5%
1/40 • Number of events 1
|
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