Trial Outcomes & Findings for A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations (NCT NCT00857961)
NCT ID: NCT00857961
Last Updated: 2011-01-07
Results Overview
Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Results posted on
2011-01-07
Participant Flow
Participant milestones
| Measure |
Testosterone MD-Lotion
Applied once daily for 7 days.
All study participants received each of the 4 study treatments:
3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).
1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.
3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).
4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla).
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Baseline characteristics by cohort
| Measure |
Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days.
All study participants received each of the 4 study treatments:
3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).
1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.
3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).
4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla).
|
|---|---|
|
Age Continuous
|
47.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.1 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Average Baseline Testosterone
|
193.2 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 73.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatmentPopulation: All participants received all four doses of testosterone MD-lotion.
Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Dihydrotestosterone
|
8.00 hours (h)
Interval 1.93 to 24.0
|
11.93 hours (h)
Interval 0.0 to 23.93
|
4.25 hours (h)
Interval 0.0 to 24.0
|
15.98 hours (h)
Interval 0.0 to 24.0
|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Free Testosterone
|
8.00 hours (h)
Interval 1.93 to 24.0
|
12.00 hours (h)
Interval 1.95 to 23.93
|
4.25 hours (h)
Interval 0.0 to 20.0
|
15.98 hours (h)
Interval 1.92 to 23.97
|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Total Testosterone
|
8.00 hours (h)
Interval 1.93 to 24.0
|
12.00 hours (h)
Interval 1.95 to 23.93
|
4.25 hours (h)
Interval 0.0 to 20.0
|
15.98 hours (h)
Interval 1.92 to 23.97
|
PRIMARY outcome
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatmentPopulation: All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.
Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cavg (n=21, n=20, n=21, n=21)
|
338 ng/dL
Standard Deviation 100
|
294 ng/dL
Standard Deviation 150
|
389 ng/dL
Standard Deviation 152
|
432 ng/dL
Standard Deviation 185
|
|
Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmax
|
546 ng/dL
Standard Deviation 266
|
430 ng/dL
Standard Deviation 259
|
590 ng/dL
Standard Deviation 289
|
626 ng/dL
Standard Deviation 264
|
|
Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmin
|
164 ng/dL
Standard Deviation 63
|
171 ng/dL
Standard Deviation 59
|
221 ng/dL
Standard Deviation 101
|
238 ng/dL
Standard Deviation 135
|
PRIMARY outcome
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatmentPopulation: All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.
Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmax
|
90.7 ng/dL
Standard Deviation 64.1
|
69.4 ng/dL
Standard Deviation 58.6
|
96.4 ng/dL
Standard Deviation 46.2
|
98.6 ng/dL
Standard Deviation 46.1
|
|
Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmin
|
33.3 ng/dL
Standard Deviation 14.4
|
34.6 ng/dL
Standard Deviation 26.5
|
47.8 ng/dL
Standard Deviation 29.4
|
49.4 ng/dL
Standard Deviation 26.7
|
|
Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cavg (n=21, n=20, n=21, n=21)
|
62.3 ng/dL
Standard Deviation 34.0
|
53.0 ng/dL
Standard Deviation 45.4
|
71.4 ng/dL
Standard Deviation 35.1
|
76.5 ng/dL
Standard Deviation 35.9
|
PRIMARY outcome
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatmentPopulation: All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.
Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmin
|
4.4 ng/dL
Standard Deviation 1.7
|
4.5 ng/dL
Standard Deviation 1.3
|
5.9 ng/dL
Standard Deviation 2.7
|
6.4 ng/dL
Standard Deviation 3.6
|
|
Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cmax
|
14.6 ng/dL
Standard Deviation 7.5
|
11.3 ng/dL
Standard Deviation 5.9
|
15.9 ng/dL
Standard Deviation 7.8
|
16.5 ng/dL
Standard Deviation 6.2
|
|
Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Cavg n=21, n=20, n=21, n=21)
|
8.9 ng/dL
Standard Deviation 2.6
|
7.6 ng/dL
Standard Deviation 3.1
|
10.4 ng/dL
Standard Deviation 3.9
|
11.4 ng/dL
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatmentPopulation: All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.
Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=20 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
Total Testosterone
|
107 percent fluctuation in concentration
Standard Deviation 55
|
84 percent fluctuation in concentration
Standard Deviation 34
|
91 percent fluctuation in concentration
Standard Deviation 41
|
92 percent fluctuation in concentration
Standard Deviation 36
|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
Dihydrotestosterone
|
85 percent fluctuation in concentration
Standard Deviation 47
|
68 percent fluctuation in concentration
Standard Deviation 25
|
70 percent fluctuation in concentration
Standard Deviation 29
|
65 percent fluctuation in concentration
Standard Deviation 24
|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
Free Testosterone
|
107 percent fluctuation in concentration
Standard Deviation 55
|
84 percent fluctuation in concentration
Standard Deviation 34
|
91 percent fluctuation in concentration
Standard Deviation 41
|
92 percent fluctuation in concentration
Standard Deviation 36
|
PRIMARY outcome
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatmentPopulation: All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.
Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=20 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
Free Testosterone
|
214 h*ng/dL
Standard Deviation 61
|
183 h*ng/dL
Standard Deviation 74
|
250 h*ng/dL
Standard Deviation 94
|
275 h*ng/dL
Standard Deviation 111
|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
Total Testosterone
|
8111 h*ng/dL
Standard Deviation 2394
|
7053 h*ng/dL
Standard Deviation 3594
|
9332 h*ng/dL
Standard Deviation 3639
|
10361 h*ng/dL
Standard Deviation 4436
|
|
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
Dihydrotestosterone
|
1496 h*ng/dL
Standard Deviation 816
|
1271 h*ng/dL
Standard Deviation 1090
|
1712 h*ng/dL
Standard Deviation 842
|
1836 h*ng/dL
Standard Deviation 862
|
SECONDARY outcome
Timeframe: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)Population: All participants received all four doses of testosterone-MD lotion.
A listing of adverse events is located in the Reported Adverse Events module.
Outcome measures
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 Participants
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Non-Serious Adverse Events
|
4 participants
|
5 participants
|
6 participants
|
5 participants
|
Adverse Events
3 mL (30 mg) of 1% Testosterone MD-Lotion
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3 mL (60 mg) of 2% Testosterone MD-Lotion
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mL (30 mg) of 1% Testosterone MD-Lotion
n=21 participants at risk
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
1.5 mL (30 mg) of 2% Testosterone MD-Lotion
n=21 participants at risk
Applied once daily for 7 days to one axilla.
|
3 mL (60 mg) of 2% Testosterone MD-Lotion
n=21 participants at risk
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
|
4.5 mL (90 mg) of 2% Testosterone MD-Lotion
n=21 participants at risk
Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Catheter site inflammation
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21
|
4.8%
1/21 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/21
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2
|
14.3%
3/21 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 2
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
0.00%
0/21
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Hot flush
|
0.00%
0/21
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
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