Central Precocious Puberty (CPP)
Conditions
Keywords
Central Precocious Puberty (CPP), Leuprolide Acetate (LA)
Brief summary
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.
Interventions
DRUGLeuprolide Acetate (LA)
Administered intramuscularly as an injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age). * No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. | Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Weeks 12, 20, 24, 44, and 48 | Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 and 48). |
| Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Weeks 12, 20, 24, 44, and 48 | Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48). |
| Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 | Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics). Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging. Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging. |
| Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144 | Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used. |
| Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. | Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL. |
| Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Weeks 72, 96, 120, and 144 | Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL. |
| Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Weeks 72, 96, 120, and 144 | Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing. |
| Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Weeks 72, 96, 120, and 144 | Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed |
| Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 | Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system. A ratio less than 1 indicates less advancement of bone age compared to chronological age. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled at 16 sites in the United States including Puerto Rico. The study enrolled pediatric participants with central precocious puberty (CPP) who were either naïve to treatment with a gonadotropin-releasing hormone receptor agonist (GnRHa) or who had been previously treated with a GnRHa.
Pre-assignment details
The study was conducted in 2 parts. In Part 1, leuprolide acetate (LA) 45 mg 6-month depot formulation was evaluated from Baseline to Week 48. Following completion of Part 1 assessments, participants continued in Part 2 (extension period) to evaluate long-term treatment of LA 45 mg 6-month depot formulation (up to 24 months).
Participants by arm
| Arm | Count |
|---|---|
| Leuprolide Acetate - Previously Treated Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1. | 18 |
| Leuprolide Acetate - Treament Naïve Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1. | 27 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other, Not Specified | 8 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Leuprolide Acetate - Treament Naïve | Leuprolide Acetate - Previously Treated |
|---|---|---|---|
| Age at onset of CPP Females | 6.4 years STANDARD_DEVIATION 1.74 | 6.7 years STANDARD_DEVIATION 0.99 | 5.9 years STANDARD_DEVIATION 2.37 |
| Age at onset of CPP Males | 5.7 years STANDARD_DEVIATION 3.19 | 6.9 years STANDARD_DEVIATION 2.58 | 2.1 years |
| Age at onset of CPP Overall | 6.3 years STANDARD_DEVIATION 1.86 | 6.8 years STANDARD_DEVIATION 1.18 | 5.7 years STANDARD_DEVIATION 2.46 |
| Age, Continuous | 7.8 years STANDARD_DEVIATION 1.27 | 7.7 years STANDARD_DEVIATION 0.83 | 8.1 years STANDARD_DEVIATION 1.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 9 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 18 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 18 Participants | 12 Participants |
| Sex: Female, Male Female | 41 Participants | 24 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 27 |
| other Total, other adverse events | 18 / 18 | 27 / 27 |
| serious Total, serious adverse events | 0 / 18 | 1 / 27 |
Outcome results
Primary
Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Time frame: Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Population: The Full Analysis Set (FAS) consists of all participants who received at least 1 dose of study drug. Participants with missing GnRHa-stimulated LH results at Week 24 were counted as not achieving suppression.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Leuprolide Acetate - Previously Treated | Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | 94.4 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | 81.5 percentage of participants |
| Leuprolide Acetate - Overall | Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 | 86.7 percentage of participants |
Secondary
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 and 48).
Time frame: Weeks 12, 20, 24, 44, and 48
Population: Full analysis set; female participants with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 20 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 44 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 12 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 24 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 48 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 24 | 95.2 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 44 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 48 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 20 | 95.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 12 | 95.5 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 48 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 12 | 97.4 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 20 | 97.4 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 24 | 97.4 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 | Week 44 | 100.0 percentage of participants |
Secondary
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48).
Time frame: Weeks 12, 20, 24, 44, and 48
Population: Full analysis set; male participants with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 44 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 24 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 12 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 20 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 48 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 24 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 12 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 20 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 44 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 48 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 48 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 44 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 12 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 24 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 | Week 20 | 100.0 percentage of participants |
Secondary
Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Time frame: Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Population: The Full Analysis Set (FAS) consists of all participants who received at least 1 dose of study drug. Participants with missing GnRHa-stimulated LH results at a specific visit were counted as not achieving suppression for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 12 | 83.3 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 20 | 94.4 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 44 | 88.9 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 48 | 83.3 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 48 | 92.6 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 12 | 88.9 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 44 | 88.9 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 20 | 85.2 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 48 | 88.9 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 20 | 88.9 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 44 | 88.9 percentage of participants |
| Leuprolide Acetate - Overall | Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 | Week 12 | 86.7 percentage of participants |
Secondary
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing.
Time frame: Weeks 72, 96, 120, and 144
Population: Full analysis set; participants with non-missing observations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 72 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 96 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 72 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 96 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 96 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL | Week 72 | 100.0 percentage of participants |
Secondary
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed
Time frame: Weeks 72, 96, 120, and 144
Population: Full analysis set; participants with non-missing observations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 72 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 96 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 72 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 96 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 96 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL | Week 72 | 100.0 percentage of participants |
Secondary
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Time frame: Weeks 72, 96, 120, and 144
Population: Full analysis set; observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 72 | 88.2 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 96 | 93.3 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 72 | 96.2 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 96 | 95.7 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 144 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 96 | 94.7 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 120 | 100.0 percentage of participants |
| Leuprolide Acetate - Overall | Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) | Week 72 | 93.0 percentage of participants |
Secondary
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used.
Time frame: Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144
Population: Full analysis set; participants with available data at Baseline (43 participants) and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 20 | -0.5 cm/year | Standard Deviation 2.61 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 24 | -0.5 cm/year | Standard Deviation 2.81 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 144 | -1.0 cm/year | Standard Deviation 1.63 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 120 | -1.2 cm/year | Standard Deviation 1.96 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 44 | -0.4 cm/year | Standard Deviation 2.48 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 4 | -0.6 cm/year | Standard Deviation 9.99 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 12 | -0.6 cm/year | Standard Deviation 4.09 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 48 | -0.3 cm/year | Standard Deviation 2.67 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 96 | -0.6 cm/year | Standard Deviation 2.29 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 72 | -0.5 cm/year | Standard Deviation 2.09 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 12 | -2.9 cm/year | Standard Deviation 5.42 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 72 | -4.3 cm/year | Standard Deviation 3.53 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 96 | -4.9 cm/year | Standard Deviation 3.43 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 120 | -5.6 cm/year | Standard Deviation 3.27 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 144 | -5.3 cm/year | Standard Deviation 2.76 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 20 | -3.8 cm/year | Standard Deviation 4.69 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 4 | -0.9 cm/year | Standard Deviation 10.52 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 24 | -3.7 cm/year | Standard Deviation 4.28 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 44 | -4.1 cm/year | Standard Deviation 3.77 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 48 | -3.5 cm/year | Standard Deviation 4.71 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 144 | -4.0 cm/year | Standard Deviation 3.19 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 4 | -0.8 cm/year | Standard Deviation 10.19 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 12 | -2.0 cm/year | Standard Deviation 5.02 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 20 | -2.5 cm/year | Standard Deviation 4.28 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 24 | -2.4 cm/year | Standard Deviation 4.03 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 44 | -2.6 cm/year | Standard Deviation 3.76 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 48 | -2.3 cm/year | Standard Deviation 4.32 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 72 | -2.8 cm/year | Standard Deviation 3.55 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 120 | -3.9 cm/year | Standard Deviation 3.54 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Change From Baseline in Incremental Growth Rate | Week 96 | -3.2 cm/year | Standard Deviation 3.68 |
Secondary
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics). Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging. Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging.
Time frame: Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Population: Full analysis set; results for males and females (with an assessment at each time point) are reported separately.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 24 | 94.1 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 48 | 88.2 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 72 | 93.8 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 96 | 100 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 120 | 91.7 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 144 | 83.3 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 24 | 0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 48 | 100 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 72 | 0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 96 | 100 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 120 | 0 percentage of participants |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 144 | 0 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 144 | 100 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 24 | 91.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 24 | 66.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 72 | 66.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 48 | 91.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 144 | 87.5 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 120 | 66.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 72 | 95.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 48 | 66.7 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 120 | 89.5 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 96 | 90.5 percentage of participants |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 96 | 66.7 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 96 | 94.3 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 120 | 90.3 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 96 | 75.0 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 144 | 86.4 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 24 | 50.0 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 48 | 75.0 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 120 | 50.0 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 24 | 92.7 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 48 | 90.2 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 72 | 50.0 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Females: Week 72 | 94.9 percentage of participants |
| Leuprolide Acetate - Overall | Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty | Males: Week 144 | 50.0 percentage of participants |
Secondary
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system. A ratio less than 1 indicates less advancement of bone age compared to chronological age.
Time frame: Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Population: Full analysis set; based on non missing observations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 48 | 0.2 ratio | Standard Deviation 1.36 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 144 | 0.6 ratio | Standard Deviation 0.26 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 24 | 0.5 ratio | Standard Deviation 0.8 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 72 | 0.6 ratio | Standard Deviation 0.31 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 96 | 0.6 ratio | Standard Deviation 0.32 |
| Leuprolide Acetate - Previously Treated | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 120 | 0.5 ratio | Standard Deviation 0.28 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 96 | 0.7 ratio | Standard Deviation 0.28 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 120 | 0.6 ratio | Standard Deviation 0.34 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 72 | 0.6 ratio | Standard Deviation 0.38 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 24 | 0.7 ratio | Standard Deviation 0.56 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 144 | 0.6 ratio | Standard Deviation 0.24 |
| Leuprolide Acetate - Treament Naïve | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 48 | 0.6 ratio | Standard Deviation 0.41 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 144 | 0.6 ratio | Standard Deviation 0.24 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 48 | 0.5 ratio | Standard Deviation 0.93 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 72 | 0.6 ratio | Standard Deviation 0.35 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 96 | 0.6 ratio | Standard Deviation 0.29 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 120 | 0.6 ratio | Standard Deviation 0.32 |
| Leuprolide Acetate - Overall | Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age | Week 24 | 0.6 ratio | Standard Deviation 0.66 |