Trial Outcomes & Findings for The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel (NCT NCT01893281)
NCT ID: NCT01893281
Last Updated: 2014-10-27
Results Overview
Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) \* 100.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
78 participants
Primary outcome timeframe
Baseline through Study Completion (Up to 9 Weeks)
Results posted on
2014-10-27
Participant Flow
Participant milestones
| Measure |
Topical Testosterone Solution
Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
78
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Topical Testosterone Solution
Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
Baseline characteristics by cohort
| Measure |
Topical Testosterone Solution
n=78 Participants
Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 10.93 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Completion (Up to 9 Weeks)Population: All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.
Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) \* 100.
Outcome measures
| Measure |
Topical Testosterone Solution
n=76 Participants
Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Percentage of Participants Achieving Normal Serum Testosterone Levels
|
94.7 percentage of participants
Interval 87.0 to 99.0
|
SECONDARY outcome
Timeframe: Baseline, Study Completion (Up to 9 Weeks)Population: All enrolled participants who received at least 1 dose of study drug with non-missing data at baseline and at least 1 post baseline measurement. Last-observation-carried-forward (LOCF) was used to impute missing data.
Serum testosterone levels were measured by LC/MS-MS.
Outcome measures
| Measure |
Topical Testosterone Solution
n=76 Participants
Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Change From Baseline in Serum Testosterone Levels
|
354.8 ng/dL
Standard Deviation 280.99
|
SECONDARY outcome
Timeframe: Study Days 15, 22, 36, 43, 57, 64 and endpointPopulation: All enrolled participants who received at least 1 dose of study drug and responded to PGI-I sexual drive questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for sexual drive collected from Day 15 through end of study.
PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was "very much better," a score of 4 indicated that the participant had experienced "no change" in sexual drive and a score of 7 indicated that the participant's sexual drive was "very much worse". Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) \* 100.
Outcome measures
| Measure |
Topical Testosterone Solution
n=77 Participants
Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Day 43 (n=22)
|
4.55 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Day 43 (n=22)
|
22.73 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Day 43 (n=22)
|
36.36 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Day 43 (n=22)
|
31.82 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Day 43 (n=22)
|
4.55 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Day 43 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Day 43 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Day 57 (n=6)
|
50.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Day 57 (n=6)
|
50.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Day 64 (n=6)
|
16.67 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Day 64 (n=6)
|
33.33 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Day 64 (n=6)
|
50.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Endpoint (n=77)
|
7.79 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Endpoint (n=77)
|
27.27 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Endpoint (n=77)
|
35.06 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Endpoint (n=77)
|
28.57 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Endpoint (n=77)
|
1.30 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Endpoint (n=77)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Endpoint (n=77)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Day 15 (n=76)
|
3.95 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Day 15 (n=76)
|
11.84 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Day 15 (n=76)
|
44.74 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Day 15 (n=76)
|
38.16 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Day 15 (n=76)
|
1.32 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Day 15 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Day 15 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Day 22 (n=76)
|
5.26 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Day 22 (n=76)
|
25.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Day 22 (n=76)
|
39.47 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Day 22 (n=76)
|
30.26 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Day 22 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Day 22 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Day 22 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much better - Day 36 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much better - Day 36 (n=22)
|
22.73 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little better - Day 36 (n=22)
|
45.45 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
No change - Day 36 (n=22)
|
31.82 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
A little worse - Day 36 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Much worse - Day 36 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
Very much worse - Day 36 (n=22)
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 15, 22, 36, 43, 57, 64 and endpointPopulation: All enrolled participants who received at least 1 dose of study drug and responded to PGI-I energy level questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for energy level collected from Day 15 through end of study.
PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was "very much better," a score of 4 indicated that the participant had experienced "no change" in energy level and a score of 7 indicated that the participant's energy level was "very much worse". Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) \* 100.
Outcome measures
| Measure |
Topical Testosterone Solution
n=77 Participants
Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Endpoint (n=77)
|
22.08 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Day 15 (n=75)
|
4.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Day 15 (n=75)
|
16.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Day 15 (n=75)
|
44.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Day 15 (n=75)
|
36.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Day 15 (n=75)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Day 15 (n=75)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Day 15 (n=75)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Day 22 (n=76)
|
7.89 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Day 22 (n=76)
|
27.63 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Day 22 (n=76)
|
40.79 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Day 22 (n=76)
|
22.37 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Day 22 (n=76)
|
1.32 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Day 22 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Day 22 (n=76)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Day 36 (n=22)
|
4.55 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Day 36 (n=22)
|
18.18 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Day 36 (n=22)
|
50.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Day 36 (n=22)
|
22.73 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Day 36 (n=22)
|
4.55 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Day 36 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Day 36 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Day 43 (n=22)
|
4.55 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Day 43 (n=22)
|
27.27 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Day 43 (n=22)
|
40.91 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Day 43 (n=22)
|
22.73 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Day 43 (n=22)
|
4.55 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Day 43 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Day 43 (n=22)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Day 57 (n=6)
|
33.33 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Day 57 (n=6)
|
50.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Day 57 (n=6)
|
16.67 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Day 57 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Day 64 (n=6)
|
16.67 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Day 64 (n=6)
|
16.67 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Day 64 (n=6)
|
33.33 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
No change - Day 64 (n=6)
|
33.33 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Day 64 (n=6)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much better - Endpoint (n=77)
|
10.39 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much better - Endpoint (n=77)
|
29.87 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little better - Endpoint (n=77)
|
35.06 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
A little worse - Endpoint (n=77)
|
2.60 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Much worse - Endpoint (n=77)
|
0.00 percentage of participants
|
|
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
Very much worse - Endpoint (n=77)
|
0.00 percentage of participants
|
Adverse Events
Topical Testosterone Solution
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topical Testosterone Solution
n=78 participants at risk
Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
1.3%
1/78 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.1%
4/78 • Number of events 4
|
|
Reproductive system and breast disorders
Testicular atrophy
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Number of events 1
|
|
General disorders
Application site pain
|
2.6%
2/78 • Number of events 2
|
|
General disorders
Influenza like illness
|
1.3%
1/78 • Number of events 1
|
|
General disorders
Irritability
|
1.3%
1/78 • Number of events 1
|
|
Immune system disorders
Allergy to animal
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Blood pressure diastolic abnormal
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Blood pressure diastolic decreased
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Blood pressure increased
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Blood pressure systolic decreased
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Heart rate decreased
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Heart rate increased
|
2.6%
2/78 • Number of events 2
|
|
Investigations
Weight increased
|
1.3%
1/78 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.3%
1/78 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/78 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/78 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.3%
1/78 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.3%
1/78 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.6%
2/78 • Number of events 2
|
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