Trial Outcomes & Findings for Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome (NCT NCT01585831)
NCT ID: NCT01585831
Last Updated: 2021-08-10
Results Overview
A collection of subtests from the Delis-Kaplan Executive Function System will be used to evaluate different domains of executive functions including planning, problem solving, fluency, inhibition, and working memory. Possible scaled scores range from 0-20 (mean of 10), with higher scores indicating better performance. The value of the change in scaled score from baseline is reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Visit 1 (baseline) and Visit 5 (1 year)
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Testosterone Gel 1%
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
20
|
|
Overall Study
COMPLETED
|
26
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Testosterone Gel 1%
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome
Baseline characteristics by cohort
| Measure |
Testosterone Gel 1%
n=28 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=20 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.23 years
STANDARD_DEVIATION 1.15 • n=5 Participants
|
12.22 years
STANDARD_DEVIATION 1.55 • n=7 Participants
|
12.22 years
STANDARD_DEVIATION 1.31 • 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
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 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
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
18 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
A collection of subtests from the Delis-Kaplan Executive Function System will be used to evaluate different domains of executive functions including planning, problem solving, fluency, inhibition, and working memory. Possible scaled scores range from 0-20 (mean of 10), with higher scores indicating better performance. The value of the change in scaled score from baseline is reported.
Outcome measures
| Measure |
Testosterone Gel 1%
n=25 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=17 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Delis-Kaplan Executive Function System
Verbal Fluency
|
-0.72 Scaled scores
Standard Deviation 2.35
|
1.29 Scaled scores
Standard Deviation 3.0
|
|
Change From Baseline on the Delis-Kaplan Executive Function System
Color-Word Interference
|
1.28 Scaled scores
Standard Deviation 3.1
|
0.65 Scaled scores
Standard Deviation 2.71
|
|
Change From Baseline on the Delis-Kaplan Executive Function System
Sorting
|
0.75 Scaled scores
Standard Deviation 3.24
|
0.76 Scaled scores
Standard Deviation 1.82
|
|
Change From Baseline on the Delis-Kaplan Executive Function System
20 Questions
|
0.60 Scaled scores
Standard Deviation 2.99
|
1.59 Scaled scores
Standard Deviation 4.06
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
This test evaluates many aspects of motor functioning including fine and gross motor skills, visual motor integration, motor planning, and motor coordination. Possible scores range from 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=26 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=17 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2
Baseline
|
39.92 score on a scale
Standard Deviation 7.55
|
35.52 score on a scale
Standard Deviation 6.38
|
|
Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2
1 Year
|
41.34 score on a scale
Standard Deviation 7.96
|
37.17 score on a scale
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=26 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=18 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Conners Parent Rating Scales: DSM Attention
Baseline
|
64.2 score on a scale
Standard Deviation 10.6
|
62.8 score on a scale
Standard Deviation 8.8
|
|
Change From Baseline on the Conners Parent Rating Scales: DSM Attention
1 Year
|
58.1 score on a scale
Standard Deviation 11.4
|
59.3 score on a scale
Standard Deviation 12.1
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=26 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=18 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity
Baseline
|
60.7 score on a scale
Standard Deviation 10.7
|
57.2 score on a scale
Standard Deviation 10.1
|
|
Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity
1 Year
|
53.4 score on a scale
Standard Deviation 10.5
|
54.4 score on a scale
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=25 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=17 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Conners Parent Rating Scales: Anxiety
Baseline
|
59.7 score on a scale
Standard Deviation 12.7
|
62.2 score on a scale
Standard Deviation 13.7
|
|
Change From Baseline on the Conners Parent Rating Scales: Anxiety
1 Year
|
54.0 score on a scale
Standard Deviation 10.4
|
62.8 score on a scale
Standard Deviation 18.8
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=26 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=17 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Conners Parent Rating Scales: Social Skills
Baseline
|
64.3 score on a scale
Standard Deviation 14.0
|
66.4 score on a scale
Standard Deviation 14.6
|
|
Change From Baseline on the Conners Parent Rating Scales: Social Skills
1 Year
|
62.7 score on a scale
Standard Deviation 14.6
|
63.2 score on a scale
Standard Deviation 15.0
|
PRIMARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=25 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=17 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Conners Parent Rating Scales: Emotional Lability
Baseline
|
59.4 score on a scale
Standard Deviation 14.1
|
61.3 score on a scale
Standard Deviation 16.4
|
|
Change From Baseline on the Conners Parent Rating Scales: Emotional Lability
1 Year
|
57.3 score on a scale
Standard Deviation 13.9
|
54.4 score on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
The Vineland-2 is an interview evaluating adaptive skills in the areas of communication, daily living skills, social skills, and motor skills. Possible scores range from 20 to 160 (mean 100), with higher scores indicating a better outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=25 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=14 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Vineland Adaptive Behavior Scales - 2nd Edition
Baseline
|
78.7 score on a scale
Standard Deviation 8.6
|
75.8 score on a scale
Standard Deviation 10.3
|
|
Change From Baseline on the Vineland Adaptive Behavior Scales - 2nd Edition
Change at 1 year
|
82.2 score on a scale
Standard Deviation 9.8
|
78.4 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
This standardized assessment of cognitive functioning allows for evaluation of verbal and nonverbal cognitive skills, working memory, and processing speed. Possible full scale IQ scores range from 40-180 (mean 100), with higher scores indicating a better outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=24 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=17 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Wechsler Intelligence Scale for Children - Fourth Edition
Baseline
|
86.8 score on a scale
Standard Deviation 16.1
|
83.9 score on a scale
Standard Deviation 14.1
|
|
Change From Baseline on the Wechsler Intelligence Scale for Children - Fourth Edition
1 Year
|
88.7 score on a scale
Standard Deviation 18.8
|
84.6 score on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)Population: Variability in participants analyzed for each outcome measure is due to participant inability to complete the measure or missing study visits.
This standardized test evaluates reading and language skills. Possible scores range from 20-200 (Mean Standard Score 100), with higher scores indicating a better outcome.
Outcome measures
| Measure |
Testosterone Gel 1%
n=24 Participants
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=16 Participants
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Change From Baseline on the Comprehensive Test of Phonological Processing
Baseline
|
77.0 score on a scale
Standard Deviation 14.1
|
78.1 score on a scale
Standard Deviation 15.9
|
|
Change From Baseline on the Comprehensive Test of Phonological Processing
Change at 1 Year
|
77.1 score on a scale
Standard Deviation 14.3
|
77.4 score on a scale
Standard Deviation 17.8
|
Adverse Events
Testosterone Gel 1%
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo Gel
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Gel 1%
n=28 participants at risk
Testosterone gel 1% applied to skin once per day for 1 year. Starting dose 1.25mL per day, titrated in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day. Titration based on testosterone levels with target level in mid-range of normal for Tanner stage.
Testosterone gel 1%: Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
|
Placebo Gel
n=20 participants at risk
Placebo gel applied to skin once per day for 1 year. Starting dose 1.25mL per day. Dose randomly adjusted in 1.25mL increments for 1st 6 months of study after each study visit up to maximum of 5.0mL per day.
Placebo gel: The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
25.0%
7/28 • Number of events 7 • 12 Months
|
30.0%
6/20 • Number of events 6 • 12 Months
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.1%
2/28 • Number of events 2 • 12 Months
|
0.00%
0/20 • 12 Months
|
|
Psychiatric disorders
Behavioral agitation
|
35.7%
10/28 • Number of events 10 • 12 Months
|
25.0%
5/20 • Number of events 5 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Skin reaction at application site
|
10.7%
3/28 • Number of events 3 • 12 Months
|
10.0%
2/20 • Number of events 2 • 12 Months
|
|
Endocrine disorders
Gynecomstia
|
3.6%
1/28 • Number of events 1 • 12 Months
|
10.0%
2/20 • Number of events 2 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Scrotal Itching
|
14.3%
4/28 • Number of events 4 • 12 Months
|
10.0%
2/20 • Number of events 2 • 12 Months
|
|
Blood and lymphatic system disorders
Low White Blood Cell count
|
28.6%
8/28 • Number of events 8 • 12 Months
|
20.0%
4/20 • Number of events 4 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Advance bone age >1 year
|
46.4%
13/28 • Number of events 13 • 12 Months
|
20.0%
4/20 • Number of events 4 • 12 Months
|
|
Hepatobiliary disorders
Transaminase elevation >ULN
|
89.3%
25/28 • Number of events 25 • 12 Months
|
75.0%
15/20 • Number of events 15 • 12 Months
|
|
Endocrine disorders
Testosterone effects in female caregiver
|
7.1%
2/28 • Number of events 2 • 12 Months
|
5.0%
1/20 • Number of events 1 • 12 Months
|
|
Metabolism and nutrition disorders
Elevated Triglycerides >250mg/dL
|
3.6%
1/28 • Number of events 1 • 12 Months
|
20.0%
4/20 • Number of events 4 • 12 Months
|
|
Psychiatric disorders
BASC-2 Critical Item change
|
46.4%
13/28 • Number of events 13 • 12 Months
|
45.0%
9/20 • Number of events 9 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place