Trial Outcomes & Findings for Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty (NCT NCT02452931)
NCT ID: NCT02452931
Last Updated: 2020-06-02
Results Overview
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
6 months
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
Assigned Intervention
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Overall number of participants represents the Safety population. The Study analysis used the Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Baseline characteristics by cohort
| Measure |
Assigned Intervention
n=64 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Age, Continuous
|
7.5 years
STANDARD_DEVIATION 0.89 • n=64 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Unwilling to Provide
|
1 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
36 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Not hispanic or Latino
|
28 Participants
n=64 Participants
|
|
Region of Enrollment
New Zealand
|
2 participants
n=64 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=64 Participants
|
|
Region of Enrollment
Argentina
|
13 participants
n=64 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=64 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=64 Participants
|
|
Region of Enrollment
Chile
|
9 participants
n=64 Participants
|
|
Luteinizing Hormone
|
23.46 IU/L
STANDARD_DEVIATION 24.282 • n=62 Participants • The Overall number of participants represents the Safety population. The Study analysis used the Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
|
54 Participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Percentage of subjects with suppressed serum LH concentrations(\<4 IU/L) 30 minutes post GnRHa stimulation test at all assessed timepoints.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.
Visit 3, Week 12
|
51 Participants
|
|
Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.
Visit 5, Week 24
|
54 Participants
|
|
Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.
Visit 6, Week 36
|
50 Participants
|
|
Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.
End of Treatment, Week 48
|
50 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Changes in height velocity (growth rate) at all study timepoints after Screening to end of study. Growth velocity is defined for each visit as change from baseline / \[(number of weeks since baseline)/52\]. Week 48: Change from Week 24 growth velocity is defined as change from week 24 to week 48 / \[(number of weeks since week 24)/52\].
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Changes in Height Velocity (Growth Rate)
Visit 2, Week 4
|
8.89 cm/year
Standard Deviation 13.128
|
|
Changes in Height Velocity (Growth Rate)
Visit 3, Week 12
|
8.30 cm/year
Standard Deviation 4.782
|
|
Changes in Height Velocity (Growth Rate)
Visit 4, Week 20
|
6.66 cm/year
Standard Deviation 3.155
|
|
Changes in Height Velocity (Growth Rate)
Visit 5, Week 24
|
6.90 cm/year
Standard Deviation 3.074
|
|
Changes in Height Velocity (Growth Rate)
Visit 6, Week 36
|
6.48 cm/year
Standard Deviation 2.272
|
|
Changes in Height Velocity (Growth Rate)
Visit 7, Week 44
|
6.23 cm/year
Standard Deviation 1.953
|
|
Changes in Height Velocity (Growth Rate)
End of Treatment, Week 48
|
6.37 cm/year
Standard Deviation 1.893
|
|
Changes in Height Velocity (Growth Rate)
End of Treatment, Week 48: Change from Week 24
|
5.79 cm/year
Standard Deviation 2.213
|
SECONDARY outcome
Timeframe: Week 24 and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Bone Age Ratio to Chronological Age at Time of Measurement
Baseline
|
1.39 Ratio
Standard Deviation 0.160
|
|
Bone Age Ratio to Chronological Age at Time of Measurement
Visit 5, Week 24
|
1.34 Ratio
Standard Deviation 0.138
|
|
Bone Age Ratio to Chronological Age at Time of Measurement
End of Treatment, Week 48
|
1.32 Ratio
Standard Deviation 0.143
|
|
Bone Age Ratio to Chronological Age at Time of Measurement
Minimum Post-baseline Value
|
1.30 Ratio
Standard Deviation 0.138
|
|
Bone Age Ratio to Chronological Age at Time of Measurement
Maximum Post-baseline Value
|
1.36 Ratio
Standard Deviation 0.138
|
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
The percent change from baseline in height at each available post-baseline measurement. Percent change is defined as (((change from Baseline)/(Baseline)) x 100).
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Percent Change From Baseline in Height
Visit 2, Week 4
|
0.5 Percent change
Standard Deviation 0.78
|
|
Percent Change From Baseline in Height
Visit 3, Week 12
|
1.4 Percent change
Standard Deviation 0.82
|
|
Percent Change From Baseline in Height
Visit 4, Week 20
|
1.9 Percent change
Standard Deviation 0.89
|
|
Percent Change From Baseline in Height
Visit 5, Week 24
|
2.3 Percent change
Standard Deviation 1.06
|
|
Percent Change From Baseline in Height
Visit 6, Week 36
|
3.3 Percent change
Standard Deviation 1.17
|
|
Percent Change From Baseline in Height
Visit 7, Week 44
|
3.9 Percent change
Standard Deviation 1.26
|
|
Percent Change From Baseline in Height
End of Treatment, Week 48
|
4.3 Percent change
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
Outcome measures
| Measure |
Assigned Intervention
n=2 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Tanner Scores: Boys - Development of External Genitalia
Baseline
|
3.0 Score on a scale
Standard Deviation 0.00
|
|
Tanner Scores: Boys - Development of External Genitalia
Visit 3, Week 12
|
2.5 Score on a scale
Standard Deviation 0.71
|
|
Tanner Scores: Boys - Development of External Genitalia
Visit 5, Week 24
|
2.5 Score on a scale
Standard Deviation 0.71
|
|
Tanner Scores: Boys - Development of External Genitalia
Visit 6, Week 36
|
2.5 Score on a scale
Standard Deviation 0.71
|
|
Tanner Scores: Boys - Development of External Genitalia
End of Treatment, Week 48
|
2.0 Score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
Outcome measures
| Measure |
Assigned Intervention
n=2 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)
Visit 3, Week 12
|
-0.5 Score on a scale
Standard Deviation 0.71
|
|
Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)
Visit 5, Week 24
|
-0.5 Score on a scale
Standard Deviation 0.71
|
|
Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)
Visit 6, Week 36
|
-0.5 Score on a scale
Standard Deviation 0.71
|
|
Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)
End of Treatment, Week 48
|
-1.0 Score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Tanner Scores: Boys and Girls - Pubic Hair
Baseline
|
2.3 Score on a scale
Standard Deviation 0.81
|
|
Tanner Scores: Boys and Girls - Pubic Hair
Visit 3, Week 12
|
2.4 Score on a scale
Standard Deviation 0.89
|
|
Tanner Scores: Boys and Girls - Pubic Hair
Visit 5, Week 24
|
2.5 Score on a scale
Standard Deviation 0.92
|
|
Tanner Scores: Boys and Girls - Pubic Hair
Visit 6, Week 36
|
2.3 Score on a scale
Standard Deviation 0.94
|
|
Tanner Scores: Boys and Girls - Pubic Hair
End of Treatment, Week 48
|
2.4 Score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)
Visit 6, Week 36
|
0.1 Score on a scale
Standard Deviation 0.60
|
|
Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)
End of Treatment, Week 48
|
0.1 Score on a scale
Standard Deviation 0.58
|
|
Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)
Visit 3, Week 12
|
0.1 Score on a scale
Standard Deviation 0.56
|
|
Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)
Visit 5, Week 24
|
0.1 Score on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
Outcome measures
| Measure |
Assigned Intervention
n=60 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Tanner Scores: Girls - Breast Development
Baseline
|
3.2 Score on a scale
Standard Deviation 0.61
|
|
Tanner Scores: Girls - Breast Development
Visit 3, Week 12
|
2.7 Score on a scale
Standard Deviation 0.90
|
|
Tanner Scores: Girls - Breast Development
Visit 5, Week 24
|
2.6 Score on a scale
Standard Deviation 1.0
|
|
Tanner Scores: Girls - Breast Development
Visit 6, Week 36
|
2.5 Score on a scale
Standard Deviation 0.89
|
|
Tanner Scores: Girls - Breast Development
End of Treatment, Week 48
|
2.4 Score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing. Tanner Stages: I (\<10yrs), II (10-11yrs), III (11-13yrs), IV (13-14yrs), V (\>14yrs).
Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
Outcome measures
| Measure |
Assigned Intervention
n=60 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Tanner Scores: Girls - Breast Development (Change From Baseline)
Visit 3, Week 12
|
-0.5 Score on a scale
Standard Deviation 0.90
|
|
Tanner Scores: Girls - Breast Development (Change From Baseline)
Visit 5, Week 24
|
-0.6 Score on a scale
Standard Deviation 0.87
|
|
Tanner Scores: Girls - Breast Development (Change From Baseline)
Visit 6, Week 36
|
-0.6 Score on a scale
Standard Deviation 0.86
|
|
Tanner Scores: Girls - Breast Development (Change From Baseline)
End of Treatment, Week 48
|
-0.7 Score on a scale
Standard Deviation 0.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Baseline, Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Height at each available measurement point. Baseline is defined as the last non-missing height measurement collected prior to or on the date of first injection.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Height
Screening
|
136.17 cm
Standard Deviation 8.292
|
|
Height
Baseline
|
136.61 cm
Standard Deviation 8.071
|
|
Height
Visit 2, Week 4
|
137.32 cm
Standard Deviation 8.201
|
|
Height
Visit 3, Week 12
|
138.52 cm
Standard Deviation 8.284
|
|
Height
Visit 4, Week 20
|
138.87 cm
Standard Deviation 8.070
|
|
Height
Visit 5, Week 24
|
139.78 cm
Standard Deviation 8.206
|
|
Height
Visit 6, Week 36
|
140.99 cm
Standard Deviation 8.374
|
|
Height
Visit 7, Week 44
|
141.81 cm
Standard Deviation 8.268
|
|
Height
End of Treatment, Week 48
|
142.37 cm
Standard Deviation 8.207
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Bone Age at each available measurement point.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Bone Age
Baseline
|
11.01 years
Standard Deviation 1.307
|
|
Bone Age
Visit 5, Week 24
|
11.30 years
Standard Deviation 1.238
|
|
Bone Age
End of Treatment, Week 48
|
11.65 years
Standard Deviation 1.124
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24 and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Bone age progression at each available post-baseline measurement point. Bone age progression is defined as (((change from baseline)/(baseline)) x 100), which is percent change from baseline.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Bone Age Progression
Visit 5, Week 24
|
2.91 percent change
Standard Deviation 4.607
|
|
Bone Age Progression
End of Treatment, Week 48
|
6.81 percent change
Standard Deviation 5.741
|
|
Bone Age Progression
Minimum Post-Baseline Value
|
2.91 percent change
Standard Deviation 4.607
|
|
Bone Age Progression
Maximum Post-Baseline Value
|
6.63 percent change
Standard Deviation 5.736
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24 and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Bone Age Ratio to Chronological Age at Time of Measurement (Percent Change From Baseline)
End of Treatment, Week 48
|
-4.90 percent change
Standard Deviation 4.689
|
|
Bone Age Ratio to Chronological Age at Time of Measurement (Percent Change From Baseline)
Visit 5, Week 24
|
-3.25 percent change
Standard Deviation 4.382
|
|
Bone Age Ratio to Chronological Age at Time of Measurement (Percent Change From Baseline)
Minimum Post-baseline Value
|
-6.15 percent change
Standard Deviation 3.934
|
|
Bone Age Ratio to Chronological Age at Time of Measurement (Percent Change From Baseline)
Maximum Post-baseline Value
|
-1.89 percent change
Standard Deviation 4.155
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24 and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Bone age advancement was evaluated relative to chronological age at each given measurement point. Percent change from baseline is: 100 x (the change from baseline value at the post-baseline visit / baseline value).
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Bone Age Ratio to Chronological Age at Start of Study (Percent Change From Baseline)
Visit 5, Week 24
|
2.91 percent change
Standard Deviation 4.607
|
|
Bone Age Ratio to Chronological Age at Start of Study (Percent Change From Baseline)
End of Treatment, Week 48
|
6.81 percent change
Standard Deviation 5.741
|
|
Bone Age Ratio to Chronological Age at Start of Study (Percent Change From Baseline)
Minimum Post-baseline Value
|
2.91 percent change
Standard Deviation 4.607
|
|
Bone Age Ratio to Chronological Age at Start of Study (Percent Change From Baseline)
Maximum Post-baseline Value
|
6.63 percent change
Standard Deviation 5.736
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Bone age advancement was evaluated relative to chronological age at each given measurement point. Bone Age Ratio to Chronological Age at Start of Study is bone age/age at first injection.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Bone Age Ratio to Chronological Age at Start of Study
Baseline
|
1.38 Ratio
Standard Deviation 0.158
|
|
Bone Age Ratio to Chronological Age at Start of Study
Visit 5, Week 24
|
1.42 Ratio
Standard Deviation 0.153
|
|
Bone Age Ratio to Chronological Age at Start of Study
End of Treatment, Week 48
|
1.47 Ratio
Standard Deviation 0.178
|
|
Bone Age Ratio to Chronological Age at Start of Study
Minimum Post-baseline Value
|
1.42 Ratio
Standard Deviation 0.153
|
|
Bone Age Ratio to Chronological Age at Start of Study
Maximum Post-baseline Value
|
1.47 Ratio
Standard Deviation 0.176
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2, Week 4, Week 12, Week 20, Week 24, Week 26, Week 36, Week 44, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
GnRH Antagonist Evaluation occurred for the two week period following each treatment and at each visit to assess flare symptoms. The percent of subjects who affirm (or whose parent/guardian affirms) each symptom domain in the global interview.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Injection site reactions
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Redness
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Bone Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · No GnRH Antagonist conditions reported?
|
53 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Any GnRH Antagonist Conditions Reported?
|
5 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Flare or hot flashes
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Injection site reactions
|
3 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Pain
|
2 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Redness
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Bone Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 3, Week 12 · No GnRH Antagonist conditions reported?
|
48 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Any GnRH Antagonist Conditions Reported?
|
3 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Flare or hot flashes
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Injection site reactions
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Any GnRH Antagonist Conditions Reported?
|
15 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Flare or hot flashes
|
4 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Injection site reactions
|
11 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Pain
|
9 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Bruising
|
3 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Redness
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Difficulty in urination
|
1 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Bone Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #1, Week 2 · No GnRH Antagonist conditions reported?
|
15 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Any GnRH Antagonist Conditions Reported?
|
4 Participants
|
|
GnRH Antagonist Evaluation
Visit 2, Week 4 · Flare or hot flashes
|
2 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Redness
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Bone Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 4, Week 20 · No GnRH Antagonist conditions reported?
|
53 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Any GnRH Antagonist Conditions Reported?
|
3 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Flare or hot flashes
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Injection site reactions
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Redness
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Bone Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 5, Week 24 · No GnRH Antagonist conditions reported?
|
55 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Any GnRH Antagonist Conditions Reported?
|
16 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Flare or hot flashes
|
2 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Injection site reactions
|
15 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Pain
|
15 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Redness
|
3 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Bone Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Telephone Contact #2, Week 26 · No GnRH Antagonist conditions reported?
|
6 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Any GnRH Antagonist Conditions Reported?
|
3 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Flare or hot flashes
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Injection site reactions
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Pain
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Redness
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Difficulty in urination
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Bone Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 6, Week 36 · No GnRH Antagonist conditions reported?
|
51 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Any GnRH Antagonist Conditions Reported?
|
3 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Flare or hot flashes
|
2 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Injection site reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Redness
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Bone Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · Onset of Allergic reactions
|
1 Participants
|
|
GnRH Antagonist Evaluation
Visit 7, Week 44 · No GnRH Antagonist conditions reported?
|
53 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Any GnRH Antagonist Conditions Reported?
|
1 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Flare or hot flashes
|
1 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Injection site reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Burning/Stinging
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Bruising
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Redness
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Difficulty in urination
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Bone Pain
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Aggravation of weakness or other muscle symptoms
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · Onset of Allergic reactions
|
0 Participants
|
|
GnRH Antagonist Evaluation
End of Treatment, Week 48 · No GnRH Antagonist conditions reported?
|
57 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12, Week 24, Week 36, and Week 48Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
The percentage of subjects with FSH, estradiol and testosterone suppression to prepubertal levels (FSH \< 2.5 mIU/mL, estradiol \< 20 pg/mL and testosterone \< 28.4 ng/dL) at each available time point.
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 3, Week 12 : FSH
|
37 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 3, Week 12 : Estradiol
|
58 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 3, Week 12 : Oestradiol (HS)
|
56 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 3, Week 12 : Testosterone
|
2 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 5, Week 24 : FSH
|
41 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 5, Week 24 : Estradiol
|
59 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 5, Week 24 : Oestradiol (HS)
|
58 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 5, Week 24 : Testosterone
|
2 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 6, Week 36 : FSH
|
26 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 6, Week 36 : Estradiol
|
57 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 6, Week 36 : Oestradiol (HS)
|
56 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
Visit 6, Week 36 : Testosterone
|
2 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
End of Treatment, Week 48 : FSH
|
32 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
End of Treatment, Week 48 : Estradiol
|
56 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
End of Treatment, Week 48 : Oestradiol (HS)
|
55 Participants
|
|
Percentage of Subjects With Suppression of FSH, Estradiol, Oestradiol (HS), and Testosterone Measured by Blood Levels.
End of Treatment, Week 48 : Testosterone
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening (Pre&Post GnRHa Stim Test), Baseline (0,1,4,6 hours Post-Injection), Week 4, Week 12 (Pre&Post GnRHa Stim Test), Week 20, Week 24 (Pre&Post GnRHa Stim Test), Week 36 (Pre&Post GnRHa Stim Test), Week 44, and Week 48 (Pre&Post GnRHa Stim Test)Population: Intent-to-Treat (ITT) population: Subjects providing consent/assent who received at least one dose of the study drug, fulfilled the protocol eligibility criteria, and provided at least one PD laboratory assessment post dosing.
Changes in ratio of LH/FSH at each time point from Screening to End of Study
Outcome measures
| Measure |
Assigned Intervention
n=62 Participants
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Changes in the Ratio of LH/FSH
Screening: Pre GnRHa Stimulation Test
|
0.387 Ratio
Standard Deviation 0.4675
|
|
Changes in the Ratio of LH/FSH
Screening: Post GnRHa Stimulation Test
|
2.187 Ratio
Standard Deviation 1.6713
|
|
Changes in the Ratio of LH/FSH
Baseline
|
0.604 Ratio
Standard Deviation 0.9851
|
|
Changes in the Ratio of LH/FSH
Baseline: 1 hr Post Inj
|
2.424 Ratio
Standard Deviation 2.1534
|
|
Changes in the Ratio of LH/FSH
Baseline: 1 hr Post Inj: Change from Baseline
|
1.856 Ratio
Standard Deviation 1.7277
|
|
Changes in the Ratio of LH/FSH
Baseline: 4 hr Post Inj
|
2.110 Ratio
Standard Deviation 2.3939
|
|
Changes in the Ratio of LH/FSH
Baseline: 4 hr Post Inj: Change from Baseline
|
1.542 Ratio
Standard Deviation 2.0932
|
|
Changes in the Ratio of LH/FSH
Baseline: 6 hr Post Inj
|
1.691 Ratio
Standard Deviation 1.7330
|
|
Changes in the Ratio of LH/FSH
Baseline: 6 hr Post Inj: Change from Baseline
|
1.123 Ratio
Standard Deviation 1.4378
|
|
Changes in the Ratio of LH/FSH
Week 4
|
0.843 Ratio
Standard Deviation 1.0004
|
|
Changes in the Ratio of LH/FSH
Week 4: Change from Baseline
|
0.233 Ratio
Standard Deviation 1.1425
|
|
Changes in the Ratio of LH/FSH
Week 12: Pre GnRHa Stim Test
|
0.565 Ratio
Standard Deviation 0.9100
|
|
Changes in the Ratio of LH/FSH
Week 12: Pre GnRHa Stim Test: Change from Baseline
|
-0.050 Ratio
Standard Deviation 1.0423
|
|
Changes in the Ratio of LH/FSH
Week 12: Post GnRHa Stim Test
|
1.342 Ratio
Standard Deviation 1.7934
|
|
Changes in the Ratio of LH/FSH
Week12: Post GnRHa Stim Test: Change from Baseline
|
0.721 Ratio
Standard Deviation 1.7237
|
|
Changes in the Ratio of LH/FSH
Week 20
|
0.654 Ratio
Standard Deviation 0.9806
|
|
Changes in the Ratio of LH/FSH
Week 20: Change from Baseline
|
0.068 Ratio
Standard Deviation 1.1859
|
|
Changes in the Ratio of LH/FSH
Week 24: Pre GnRHa Stim Test
|
0.611 Ratio
Standard Deviation 0.9571
|
|
Changes in the Ratio of LH/FSH
Week 24: Pre GnRHa Stim Test: Change from Baseline
|
0.007 Ratio
Standard Deviation 1.1818
|
|
Changes in the Ratio of LH/FSH
Week 24: Post GnRHa Stim Test
|
1.320 Ratio
Standard Deviation 1.2843
|
|
Changes in the Ratio of LH/FSH
Week24: Post GnRHa Stim Test: Change from Baseline
|
0.716 Ratio
Standard Deviation 1.4450
|
|
Changes in the Ratio of LH/FSH
Week 36: Pre GnRHa Stim Test
|
0.474 Ratio
Standard Deviation 0.5249
|
|
Changes in the Ratio of LH/FSH
Week 36: Pre GnRHa Stim Test: Change from Baseline
|
-0.125 Ratio
Standard Deviation 1.0038
|
|
Changes in the Ratio of LH/FSH
Week 36: Post GnRHa Stim Test
|
1.051 Ratio
Standard Deviation 1.4130
|
|
Changes in the Ratio of LH/FSH
Week36: Post GnRHa Stim Test: Change from Baseline
|
0.461 Ratio
Standard Deviation 15374
|
|
Changes in the Ratio of LH/FSH
Week 44
|
0.517 Ratio
Standard Deviation 0.7846
|
|
Changes in the Ratio of LH/FSH
Week 44: Change from Baseline
|
-0.073 Ratio
Standard Deviation 1.0575
|
|
Changes in the Ratio of LH/FSH
Week 48: Pre GnRHa Stim Test
|
0.557 Ratio
Standard Deviation 1.0957
|
|
Changes in the Ratio of LH/FSH
Week 48: Pre GnRHa Stim Test: Change from Baseline
|
-0.033 Ratio
Standard Deviation 1.2191
|
|
Changes in the Ratio of LH/FSH
Week 48: Post GnRHa Stim Test
|
1.092 Ratio
Standard Deviation 1.5655
|
|
Changes in the Ratio of LH/FSH
Week48: Post GnRHa Stim Test: Change from Baselin
|
0.509 Ratio
Standard Deviation 1.5780
|
Adverse Events
Assigned Intervention
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Assigned Intervention
n=64 participants at risk
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
Other adverse events
| Measure |
Assigned Intervention
n=64 participants at risk
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg: Subcutaneous injection
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
6/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
5/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
General disorders
Pyrexia
|
17.2%
11/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Infections and infestations
Nasopharyngitis
|
21.9%
14/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Nervous system disorders
Headache
|
15.6%
10/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
8/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.2%
4/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
4/64 • Adverse events were collected from the time ICF was signed until End of Treatment (48 weeks). Any AEs related to study drug were followed for 28 days or through resolution, stabilization, until deemed clinically insignificant, or until the subject is lost to follow-up.
Definition of Suspected Adverse Reaction is any AE for which there is reasonable possibility that the drug caused the AE. Definition of Unexpected Adverse Event is an AE or suspected adverse reaction considered unexpected if it is not listed in the ELIGARD® Package Insert, or is not listed in the Investigator Brochure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Protocol Section 11.3 Publication, the Investigator shall not make any publication related to this study without the express written permission of the Sponsor. The Investigator agrees to provide abstract, manuscript, and/or documentation for Sponsor review 90 days prior to submission for publication/presentation. The Sponsor retains the right to delete from the manuscript confidential information and to object to suggested publication and/or its timing (at the Sponsor's sole discretion).
- Publication restrictions are in place
Restriction type: OTHER