Trial Outcomes & Findings for Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty (NCT NCT00667446)
NCT ID: NCT00667446
Last Updated: 2014-01-09
Results Overview
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
Day 1, Months 6, 12, 24, and 36
Results posted on
2014-01-09
Participant Flow
Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.
At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.
Participant milestones
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
|
Leuprolide Acetate 3M Depot 30 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
|
|---|---|---|
|
Treatment Period (36 Months)
STARTED
|
34
|
38
|
|
Treatment Period (36 Months)
COMPLETED
|
11
|
13
|
|
Treatment Period (36 Months)
NOT COMPLETED
|
23
|
25
|
|
Safety Follow-up Period (12 Weeks)
STARTED
|
28
|
26
|
|
Safety Follow-up Period (12 Weeks)
COMPLETED
|
28
|
25
|
|
Safety Follow-up Period (12 Weeks)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
|
Leuprolide Acetate 3M Depot 30 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
|
|---|---|---|
|
Treatment Period (36 Months)
Ready to enter puberty based on age
|
13
|
15
|
|
Treatment Period (36 Months)
Other
|
2
|
2
|
|
Treatment Period (36 Months)
Personal reasons
|
2
|
2
|
|
Treatment Period (36 Months)
Withdrawal by Subject
|
0
|
4
|
|
Treatment Period (36 Months)
Not Adequately Suppressed on Therapy
|
3
|
0
|
|
Treatment Period (36 Months)
Lost to Follow-up
|
1
|
0
|
|
Treatment Period (36 Months)
Protocol Violation
|
1
|
1
|
|
Treatment Period (36 Months)
Therapeutic Failure
|
1
|
1
|
|
Safety Follow-up Period (12 Weeks)
No Longer Needed Treatment
|
0
|
1
|
Baseline Characteristics
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Baseline characteristics by cohort
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=34 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=38 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.50 years
STANDARD_DEVIATION 1.71 • n=5 Participants
|
8.45 years
STANDARD_DEVIATION 1.52 • n=7 Participants
|
8.47 years
STANDARD_DEVIATION 1.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Months 6, 12, 24, and 36Population: Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, \& did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=33 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=38 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Day 1 [N= 32, 37]
|
96.9 percentage of participants
Interval 83.78 to 99.92
|
100.0 percentage of participants
Interval 90.51 to 100.0
|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Month 6 [N=32, 36]
|
93.8 percentage of participants
Interval 79.19 to 99.23
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Month 12 [N=31, 32]
|
90.3 percentage of participants
Interval 74.25 to 97.96
|
96.9 percentage of participants
Interval 83.78 to 99.92
|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Month 24 [N=16, 18]
|
87.5 percentage of participants
Interval 64.65 to 98.45
|
100.0 percentage of participants
Interval 81.47 to 100.0
|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Month 36 [N=9, 11]
|
77.8 percentage of participants
Interval 39.99 to 97.19
|
100.0 percentage of participants
Interval 71.51 to 100.0
|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Final Visit [N=33, 36]
|
93.9 percentage of participants
Interval 79.77 to 99.26
|
100.0 percentage of participants
Interval 90.26 to 100.0
|
SECONDARY outcome
Timeframe: Day 1, Months 3, 6, 9, 12, and 24Population: Intention-to-treat female population. N = the number of participants with available data at each time point.
The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol \< 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=31 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=33 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Day 1 [N=28, 30]
|
96.4 percentage of participants
Interval 81.65 to 99.91
|
100.0 percentage of participants
Interval 88.43 to 100.0
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Month 3 [N=29, 33]
|
100.0 percentage of participants
Interval 88.06 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Month 6 [N=26, 25]
|
100.0 percentage of participants
Interval 86.77 to 100.0
|
100.0 percentage of participants
Interval 86.28 to 100.0
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Month 9 [N=18, 18]
|
100.0 percentage of participants
Interval 81.47 to 100.0
|
100.0 percentage of participants
Interval 81.47 to 100.0
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Month 12 [N=10, 12]
|
100.0 percentage of participants
Interval 69.15 to 100.0
|
100.0 percentage of participants
Interval 73.54 to 100.0
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Month 24 [N=1, 0]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
NA percentage of participants
No participants with available data at this time point
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Final Visit [N=31, 33]
|
100.0 percentage of participants
Interval 88.78 to 100.0
|
100.0 percentage of participants
Interval 89.42 to 100.0
|
SECONDARY outcome
Timeframe: Months 6, 9, 12, 24, 30, and 36Population: Intention-to-treat female population. N = the number of participants with available data at each time point.
The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol \< 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=31 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=33 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Month 6 [N=4, 6]
|
100.0 percentage of participants
Interval 39.76 to 100.0
|
83.3 percentage of participants
Interval 35.88 to 99.58
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Month 9 [N=13, 10]
|
61.5 percentage of participants
Interval 31.58 to 86.14
|
40.0 percentage of participants
Interval 12.16 to 73.76
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Month 12 [N=20, 15]
|
45.0 percentage of participants
Interval 23.06 to 68.47
|
60.0 percentage of participants
Interval 32.29 to 83.66
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Month 24 [N=14, 15]
|
50.0 percentage of participants
Interval 23.04 to 76.96
|
53.3 percentage of participants
Interval 26.59 to 78.73
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Month 30 [N=9, 15]
|
33.3 percentage of participants
Interval 7.49 to 70.07
|
26.7 percentage of participants
Interval 7.79 to 55.1
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Month 36 [N=7, 11]
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
36.4 percentage of participants
Interval 10.93 to 69.21
|
|
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Final Visit [N=24, 26]
|
29.2 percentage of participants
Interval 12.62 to 51.09
|
30.8 percentage of participants
Interval 14.33 to 51.79
|
SECONDARY outcome
Timeframe: Day 1, Months 3, 6, 9, 12, 24, 30, and 36Population: Intention-to-treat male population. N = the number of participants with available data at each time point.
The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone \< 30 ng/dL. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=2 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=5 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Day 1 [N= 2, 5]
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
100.0 percentage of participants
Interval 47.82 to 100.0
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 3 [N=2, 5]
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
100.0 percentage of participants
Interval 47.82 to 100.0
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 6 [N=2, 5]
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
80.0 percentage of participants
Interval 28.36 to 99.49
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 9 [N=2, 5]
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
80.0 percentage of participants
Interval 28.36 to 99.49
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 12 [N=1, 5]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 47.82 to 100.0
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 24 [N=1, 3]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 30 [N=0, 1]
|
NA percentage of participants
No participants with available data at this time point
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Month 36 [N=0, 1]
|
NA percentage of participants
No participants with available data at this time point
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Male Participants With Suppression of Basal Testosterone
Final Visit [N=2, 5]
|
100.0 percentage of participants
Interval 15.81 to 100.0
|
100.0 percentage of participants
Interval 47.82 to 100.0
|
SECONDARY outcome
Timeframe: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36Population: Intention-to-treat. N = the number of participants with available data at each time point.
Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=33 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=38 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Baseline [N=33, 38]
|
21.89 mIU/mL
Standard Deviation 38.46
|
10.16 mIU/mL
Standard Deviation 12.66
|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Day 1 [N=32, 37]
|
2.00 mIU/mL
Standard Deviation 1.03
|
1.49 mIU/mL
Standard Deviation 0.86
|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Month 6 [N=32, 36]
|
2.22 mIU/mL
Standard Deviation 1.16
|
1.62 mIU/mL
Standard Deviation 0.82
|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Month 12 [N=31, 32]
|
2.24 mIU/mL
Standard Deviation 1.20
|
1.58 mIU/mL
Standard Deviation 1.02
|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Month 24 [N=14, 18]
|
1.67 mIU/mL
Standard Deviation 0.97
|
0.88 mIU/mL
Standard Deviation 0.58
|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Month 36 [N=7, 11]
|
1.51 mIU/mL
Standard Deviation 0.85
|
0.91 mIU/mL
Standard Deviation 0.49
|
|
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Final Visit [N=33, 36]
|
1.81 mIU/mL
Standard Deviation 1.13
|
1.15 mIU/mL
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.
The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=31 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=31 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Day 1 [N= 31, 31]
|
90.3 percentage of participants
Interval 74.2 to 98.0
|
83.9 percentage of participants
Interval 66.3 to 94.5
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 3 [N=29, 31]
|
86.2 percentage of participants
Interval 68.3 to 96.1
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 6 [N=31, 30]
|
90.3 percentage of participants
Interval 74.2 to 98.0
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 9 [N=31, 28]
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
75.0 percentage of participants
Interval 55.1 to 89.3
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 12 [N=28, 26]
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
80.8 percentage of participants
Interval 60.6 to 93.4
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 18 [N=17, 20]
|
82.4 percentage of participants
Interval 56.6 to 96.2
|
75.0 percentage of participants
Interval 50.9 to 91.3
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 24 [N=14, 16]
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 30 [N=10, 16]
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Month 36 [N=8, 12]
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
66.7 percentage of participants
Interval 34.9 to 90.1
|
|
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Final Visit [N=31, 31]
|
83.9 percentage of participants
Interval 66.3 to 94.5
|
71.0 percentage of participants
Interval 52.0 to 85.8
|
SECONDARY outcome
Timeframe: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.
The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=2 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=5 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Day 1 [N= 2, 5]
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 3 [N=2, 5]
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 6 [N=2, 5]
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 9 [N=2, 5]
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 12 [N=1, 5]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 18 [N=1, 3]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 24 [N=1, 3]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 30 [N=1, 1]
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Month 36 [N=0, 1]
|
NA percentage of participants
No participants with available data at this time point
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Final Visit [N=2, 5]
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
SECONDARY outcome
Timeframe: Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36Population: Intention-to-treat with available growth rate data. N = participants with available data at each time point.
Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=32 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=38 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Change From Baseline in Growth Rate
Change from Baseline at Final Visit [N=32, 38]
|
-2.27 cm/year
Standard Deviation 3.78
|
-2.64 cm/year
Standard Deviation 2.65
|
|
Change From Baseline in Growth Rate
Baseline [N=32, 38]
|
7.2 cm/year
Standard Deviation 3.96
|
7.53 cm/year
Standard Deviation 2.81
|
|
Change From Baseline in Growth Rate
Change from Baseline at Day 1 [N=32, 38]
|
-1.67 cm/year
Standard Deviation 3.90
|
-1.65 cm/year
Standard Deviation 3.43
|
|
Change From Baseline in Growth Rate
Change from Baseline at Month 6 [N=32, 37]
|
-1.66 cm/year
Standard Deviation 3.78
|
-2.04 cm/year
Standard Deviation 2.95
|
|
Change From Baseline in Growth Rate
Change from Baseline at Month 12 [N=28, 32]
|
-1.99 cm/year
Standard Deviation 3.90
|
-2.28 cm/year
Standard Deviation 2.88
|
|
Change From Baseline in Growth Rate
Change from Baseline at Month 18 [N=18, 23]
|
-2.21 cm/year
Standard Deviation 4.29
|
-2.06 cm/year
Standard Deviation 2.40
|
|
Change From Baseline in Growth Rate
Change from Baseline at Month 24 [N=15, 19]
|
-2.36 cm/year
Standard Deviation 4.85
|
-1.59 cm/year
Standard Deviation 2.20
|
|
Change From Baseline in Growth Rate
Change from Baseline at Month 30 [N=11, 17]
|
-1.86 cm/year
Standard Deviation 5.45
|
-2.13 cm/year
Standard Deviation 2.33
|
|
Change From Baseline in Growth Rate
Change from Baseline at Month 36 [N=8, 13]
|
-2.64 cm/year
Standard Deviation 5.93
|
-2.19 cm/year
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36Population: Intention-to-treat with available bone age data. N = participants with available data at each time point.
Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula: (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline).
Outcome measures
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=33 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=37 Participants
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Day 1 [N=32, 37]
|
0.51 ratio
Standard Deviation 0.56
|
1.02 ratio
Standard Deviation 1.27
|
|
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Month 12 [N=32, 32]
|
0.52 ratio
Standard Deviation 0.33
|
0.62 ratio
Standard Deviation 0.37
|
|
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Month 24 [N=14, 17]
|
0.53 ratio
Standard Deviation 0.30
|
0.72 ratio
Standard Deviation 0.34
|
|
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Month 36 [N=5, 11]
|
0.43 ratio
Standard Deviation 0.15
|
0.64 ratio
Standard Deviation 0.30
|
|
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Final Visit [N=33, 32]
|
0.48 ratio
Standard Deviation 0.28
|
0.56 ratio
Standard Deviation 0.30
|
Adverse Events
Leuprolide Acetate 3M Depot 11.25 mg
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Leuprolide Acetate 3M Depot 30 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=34 participants at risk
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=38 participants at risk
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
2.9%
1/34 • 37 months
|
0.00%
0/38 • 37 months
|
Other adverse events
| Measure |
Leuprolide Acetate 3M Depot 11.25 mg
n=34 participants at risk
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
|
Leuprolide Acetate 3M Depot 30 mg
n=38 participants at risk
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
|
|---|---|---|
|
Ear and labyrinth disorders
EAR PAIN
|
2.9%
1/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Eye disorders
MYOPIA
|
0.00%
0/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.9%
2/34 • 37 months
|
7.9%
3/38 • 37 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.9%
2/34 • 37 months
|
7.9%
3/38 • 37 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.9%
2/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.8%
3/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Gastrointestinal disorders
NAUSEA
|
5.9%
2/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/34 • 37 months
|
10.5%
4/38 • 37 months
|
|
General disorders
INJECTION SITE PAIN
|
29.4%
10/34 • 37 months
|
23.7%
9/38 • 37 months
|
|
General disorders
PYREXIA
|
17.6%
6/34 • 37 months
|
13.2%
5/38 • 37 months
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.9%
2/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Infections and infestations
BODY TINEA
|
8.8%
3/34 • 37 months
|
0.00%
0/38 • 37 months
|
|
Infections and infestations
BRONCHITIS
|
8.8%
3/34 • 37 months
|
0.00%
0/38 • 37 months
|
|
Infections and infestations
EAR INFECTION
|
8.8%
3/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Infections and infestations
GASTROENTERITIS
|
11.8%
4/34 • 37 months
|
10.5%
4/38 • 37 months
|
|
Infections and infestations
INFLUENZA
|
8.8%
3/34 • 37 months
|
0.00%
0/38 • 37 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.8%
3/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Infections and infestations
PHARYNGITIS
|
5.9%
2/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
14.7%
5/34 • 37 months
|
10.5%
4/38 • 37 months
|
|
Infections and infestations
SINUSITIS
|
5.9%
2/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
26.5%
9/34 • 37 months
|
13.2%
5/38 • 37 months
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/34 • 37 months
|
7.9%
3/38 • 37 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.8%
4/34 • 37 months
|
13.2%
5/38 • 37 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.8%
3/34 • 37 months
|
7.9%
3/38 • 37 months
|
|
Nervous system disorders
HEADACHE
|
14.7%
5/34 • 37 months
|
15.8%
6/38 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.8%
4/34 • 37 months
|
23.7%
9/38 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.8%
3/34 • 37 months
|
13.2%
5/38 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
2.9%
1/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
8.8%
3/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Skin and subcutaneous tissue disorders
ACNE
|
5.9%
2/34 • 37 months
|
5.3%
2/38 • 37 months
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.9%
2/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
8.8%
3/34 • 37 months
|
2.6%
1/38 • 37 months
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
5.9%
2/34 • 37 months
|
0.00%
0/38 • 37 months
|
Additional Information
Global Medical Services
AbbVie, (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER