Central Precocious Puberty
Conditions
Brief summary
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).
Interventions
Triptorelin 6-month formulation for IM on day 1 and Month 6.
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
Inclusion criteria
* Participant is less than 9 years old for girls and less than 10 years old for boys at initiation of triptorelin treatment or at the time of signing the informed consent. * Participant must present evidence of CPP documented by: * Onset of development of secondary sex characteristics (breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II) before the age of 8 years in girls and 9 years in boys. * Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥6 IU/L) in both sexes. * Difference between bone age (BA) and CA \>1 year. * Girls with Tanner staging ≥2 for breast development and who have enlarged uterine length and/or ovarian volume and at last 2 follicles with diameter \>4 mm in the ovary observed by pelvic type B ultrasound at the Screening visit; boys who have testicular volume ≥4 mL observed by testicular orchidometer at the Screening visit. * Girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before the first dose of study intervention and should not be at risk of pregnancy throughout the study period.
Exclusion criteria
* Gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. * Non-progressing isolated premature thelarche. * Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible. * Prior or current therapy with a GnRHa (Gonadotropin-releasing Hormone Agonist) , medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (IGF 1).Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Luteinising Hormone (LH) Suppression | At Month 6 | LH response was defined as a peak LH \<=5 international units per liter (IU/L) after intravenous (IV) gonadotropin-releasing hormone (GnRH) stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | Baseline and at Months 3, 6, 9 and 12 | Basal LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the values for LH and FSH at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | Baseline and at Months 3, 6 and 12 | Peak LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the values for LH and FSH at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) after a single IV injection of gonadorelin. A suppressed LH response to GnRH stimulation test was defined as peak serum LH \<=5 IU/L among the four timepoints (T0, T30, T60 and T90). The FSH response to GnRH stimulation was the peak serum FSH level among the four timepoints (T0, T30, T60 and T90). |
| Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12 | Month 6 to Month 12 | Peak LH serum concentration was analyzed centrally. LH response was defined as a peak LH \<=5 IU/L after IV GnRH stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of peak LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Percentage of Participants With Prepubertal Levels of Sex Steroids | At Months 3, 6, 9 and 12 | Prepubertal sex steroids assessment included estradiol in female participants and testosterone in male participants. Prepubertal sex steroids levels were defined as: estradiol \<=20 picogram (pg)/ milliliter (mL) in female participants and testosterone \<=30 nanogram (ng)/ deciliter (dL) in male participants. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Change From Baseline in Mean Height for Age (Z-Score) | Baseline and at Months 6 and 12 | Z-scores are calculated using Centers for Disease Control and Prevention (CDC) Growth Charts. Change from baseline was defined as the values for Z-score at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to study treatment administration. Negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. |
| Change From Baseline in Percentile for Height for Age | Baseline and at Months 6 and 12 | Z-scores were calculated using CDC growth charts, that contained Box-Cox transformation (L), the median (M) and the generalized coefficient of variation (S). Percentile was obtained using the following equation M (1 + LSZ) \*\* (1/L), where \*\* indicated an exponent, such that m (1+LSZ)\*\* (1/L) meant raising (1+LSZ) to the (1/L)th power and then multiplying the M. Z was the Z-score that corresponds to the percentile. Negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline was defined as the values for percentile of Z-score at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Change From Baseline in Growth Velocity | Baseline and at Months 6 and 12 | Growth velocity analysis was part of auxological parameter. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Percentage of Participants With LH Response to GnRH Test | At Months 3 and 12 | LH response was defined as a peak LH \<=5 IU/L after IV GnRH stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Change From Baseline in BA:CA Ratio | Baseline, Months 6 and 12 | BA was determined using X-rays of the hand and wrist by Greulich and Pyle method. CA was calculated as (visit date -birth date + 1)/365.25. Change from baseline was defined as the values for BA:CA ratio at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Percentage of Participants With Stabilized Pubertal Stage | At Months 6 and 12 | Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital development stage (GDS) in male participants, breast development stage (BDS) in female participants and pubic hair development (PHD) stage in both sexes. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Percentage of Participants With Regression of Uterine Length | At Months 6 and 12 | Uterine length was determined by transabdominal ultrasound. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Percentage of Participants With Absence of Progression of Testis Volumes | At Months 6 and 12 | Testis volume was a clinical assessment with orchidometer. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100. |
| Change From Baseline in Body Mass Index (BMI) | Baseline and at Months 6 and 12 | BMI analysis was part of auxological parameter assessment. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Change From Baseline in Weight | Baseline and at Months 6 and 12 | Weight analysis was part of auxological parameter assessment. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. |
| Plasma Concentrations of Triptorelin | Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12 | Blood samples were collected at specified timepoints. |
| Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen | At Months 6 and 12 | BA was determined using X-rays of the hand and wrist by Greulich and Pyle method. CA was calculated as (visit date -birth date + 1)/365.25. Percentage of response was calculated as n/N\*100, where n was number of participants in the specified category and N was number of participants in the analysis population. |
Countries
China
Participant flow
Recruitment details
This Phase 3, open-label, single arm, study was conducted in children with central precocious puberty (CPP) at 12 investigational sites in China from 25 August 2021 to 13 February 2023.
Pre-assignment details
This study consisted of screening period (up to 28 days) and study duration of minimum 12 months and up to 13 months including screening period.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received triptorelin pamoate 22.5 mg IM injection on Day 1. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 7.5 years STANDARD_DEVIATION 0.9 |
| Race/Ethnicity, Customized Chinese | 66 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 66 Participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 66 |
| other Total, other adverse events | 59 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
Primary
Percentage of Participants With Luteinising Hormone (LH) Suppression
LH response was defined as a peak LH \<=5 international units per liter (IU/L) after intravenous (IV) gonadotropin-releasing hormone (GnRH) stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: At Month 6
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Luteinising Hormone (LH) Suppression | 100 percentage of participants |
Secondary
Change From Baseline in BA:CA Ratio
BA was determined using X-rays of the hand and wrist by Greulich and Pyle method. CA was calculated as (visit date -birth date + 1)/365.25. Change from baseline was defined as the values for BA:CA ratio at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered.
Time frame: Baseline, Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in BA:CA Ratio | Month 6 | -0.04 ratio | Standard Deviation 0.06 |
| All Participants | Change From Baseline in BA:CA Ratio | Month 12 | -0.06 ratio | Standard Deviation 0.07 |
Secondary
Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels
Basal LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the values for LH and FSH at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered.
Time frame: Baseline and at Months 3, 6, 9 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | LH, Month 3 | -1.6420 IU/L | Standard Deviation 2.4287 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | LH, Month 6 | -1.8015 IU/L | Standard Deviation 2.4109 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | LH, Month 9 | -1.6307 IU/L | Standard Deviation 2.3396 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | LH, Month 12 | -1.8504 IU/L | Standard Deviation 2.4524 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | FSH, Month 3 | -2.9938 IU/L | Standard Deviation 1.945 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | FSH, Month 6 | -2.4871 IU/L | Standard Deviation 2.0414 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | FSH, Month 9 | -2.8586 IU/L | Standard Deviation 1.931 |
| All Participants | Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | FSH, Month 12 | -2.5348 IU/L | Standard Deviation 1.9162 |
Secondary
Change From Baseline in Body Mass Index (BMI)
BMI analysis was part of auxological parameter assessment. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered.
Time frame: Baseline and at Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Body Mass Index (BMI) | Month 6 | 0.282 kilogram (kg)/meter square | Standard Deviation 0.882 |
| All Participants | Change From Baseline in Body Mass Index (BMI) | Month 12 | 1.195 kilogram (kg)/meter square | Standard Deviation 1.196 |
Secondary
Change From Baseline in Growth Velocity
Growth velocity analysis was part of auxological parameter. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered.
Time frame: Baseline and at Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Growth Velocity | Month 6 | -3.938 centimeter (cm)/year | Standard Deviation 6.075 |
| All Participants | Change From Baseline in Growth Velocity | Month 12 | -4.798 centimeter (cm)/year | Standard Deviation 5.577 |
Secondary
Change From Baseline in Mean Height for Age (Z-Score)
Z-scores are calculated using Centers for Disease Control and Prevention (CDC) Growth Charts. Change from baseline was defined as the values for Z-score at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to study treatment administration. Negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Time frame: Baseline and at Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Mean Height for Age (Z-Score) | Month 6 | 0.0734 Z-score | Standard Deviation 0.1433 |
| All Participants | Change From Baseline in Mean Height for Age (Z-Score) | Month 12 | 0.0204 Z-score | Standard Deviation 0.1567 |
Secondary
Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test
Peak LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the values for LH and FSH at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) after a single IV injection of gonadorelin. A suppressed LH response to GnRH stimulation test was defined as peak serum LH \<=5 IU/L among the four timepoints (T0, T30, T60 and T90). The FSH response to GnRH stimulation was the peak serum FSH level among the four timepoints (T0, T30, T60 and T90).
Time frame: Baseline and at Months 3, 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | LH, Month 12 | -26.6065 IU/L | Standard Deviation 20.568 |
| All Participants | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | FSH, Month 3 | -11.7297 IU/L | Standard Deviation 5.1787 |
| All Participants | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | FSH, Month 6 | -10.0656 IU/L | Standard Deviation 5.016 |
| All Participants | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | FSH, Month 12 | -10.1645 IU/L | Standard Deviation 5.2442 |
| All Participants | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | LH, Month 3 | -26.0075 IU/L | Standard Deviation 19.8863 |
| All Participants | Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | LH, Month 6 | -26.2867 IU/L | Standard Deviation 20.3004 |
Secondary
Change From Baseline in Percentile for Height for Age
Z-scores were calculated using CDC growth charts, that contained Box-Cox transformation (L), the median (M) and the generalized coefficient of variation (S). Percentile was obtained using the following equation M (1 + LSZ) \*\* (1/L), where \*\* indicated an exponent, such that m (1+LSZ)\*\* (1/L) meant raising (1+LSZ) to the (1/L)th power and then multiplying the M. Z was the Z-score that corresponds to the percentile. Negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline was defined as the values for percentile of Z-score at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered.
Time frame: Baseline and at Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Percentile for Height for Age | Month 12 | 0.2810 percentiles of Z-score | Standard Deviation 3.2237 |
| All Participants | Change From Baseline in Percentile for Height for Age | Month 6 | 1.4675 percentiles of Z-score | Standard Deviation 2.8638 |
Secondary
Change From Baseline in Weight
Weight analysis was part of auxological parameter assessment. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first study treatment administered.
Time frame: Baseline and at Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Weight | Month 6 | 2.020 kg | Standard Deviation 1.927 |
| All Participants | Change From Baseline in Weight | Month 12 | 5.146 kg | Standard Deviation 2.816 |
Secondary
Percentage of Participants With Absence of Progression of Testis Volumes
Testis volume was a clinical assessment with orchidometer. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: At Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the male participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Absence of Progression of Testis Volumes | Month 6 | 75.0 percentage of participants |
| All Participants | Percentage of Participants With Absence of Progression of Testis Volumes | Month 12 | 75.0 percentage of participants |
Secondary
Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen
BA was determined using X-rays of the hand and wrist by Greulich and Pyle method. CA was calculated as (visit date -birth date + 1)/365.25. Percentage of response was calculated as n/N\*100, where n was number of participants in the specified category and N was number of participants in the analysis population.
Time frame: At Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen | Month 6 | 95.5 percentage of participants |
| All Participants | Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen | Month 12 | 92.4 percentage of participants |
Secondary
Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12
Peak LH serum concentration was analyzed centrally. LH response was defined as a peak LH \<=5 IU/L after IV GnRH stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of peak LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: Month 6 to Month 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12 | 98.5 percentage of participants |
Secondary
Percentage of Participants With LH Response to GnRH Test
LH response was defined as a peak LH \<=5 IU/L after IV GnRH stimulation. The GnRH stimulation test was performed by using an IV injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: At Months 3 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With LH Response to GnRH Test | Month 3 | 97.0 percentage of participants |
| All Participants | Percentage of Participants With LH Response to GnRH Test | Month 12 | 98.5 percentage of participants |
Secondary
Percentage of Participants With Prepubertal Levels of Sex Steroids
Prepubertal sex steroids assessment included estradiol in female participants and testosterone in male participants. Prepubertal sex steroids levels were defined as: estradiol \<=20 picogram (pg)/ milliliter (mL) in female participants and testosterone \<=30 nanogram (ng)/ deciliter (dL) in male participants. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: At Months 3, 6, 9 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Prepubertal Levels of Sex Steroids | Month 3 | 97.0 percentage of participants |
| All Participants | Percentage of Participants With Prepubertal Levels of Sex Steroids | Month 6 | 100 percentage of participants |
| All Participants | Percentage of Participants With Prepubertal Levels of Sex Steroids | Month 9 | 86.4 percentage of participants |
| All Participants | Percentage of Participants With Prepubertal Levels of Sex Steroids | Month 12 | 98.5 percentage of participants |
Secondary
Percentage of Participants With Regression of Uterine Length
Uterine length was determined by transabdominal ultrasound. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: At Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the female participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Regression of Uterine Length | Month 6 | 64.5 percentage of participants |
| All Participants | Percentage of Participants With Regression of Uterine Length | Month 12 | 64.5 percentage of participants |
Secondary
Percentage of Participants With Stabilized Pubertal Stage
Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital development stage (GDS) in male participants, breast development stage (BDS) in female participants and pubic hair development (PHD) stage in both sexes. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Time frame: At Months 6 and 12
Population: The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | GDS for male participants, Month 6 | 100 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | GDS for male participants, Month 12 | 100 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | PHD for female participants, Month 12 | 87.1 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | PHD for female participants, Month 6 | 91.9 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | PHD for male participants, Month 6 | 100 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | BDS for female participants, Month 12 | 93.5 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | PHD for male participants, Month 12 | 75.0 percentage of participants |
| All Participants | Percentage of Participants With Stabilized Pubertal Stage | BDS for female participants, Month 6 | 98.4 percentage of participants |
Secondary
Plasma Concentrations of Triptorelin
Blood samples were collected at specified timepoints.
Time frame: Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12
Population: The Pharmacokinetic (PK) set consisted of all participants who received at 1 dose of study treatment and had at least 1 valid triptorelin concentration. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Plasma Concentrations of Triptorelin | Day 1, 4 hours post-injection | 41.8 ng/mL | Geometric Coefficient of Variation 56.9 |
| All Participants | Plasma Concentrations of Triptorelin | Month 3 | 0.0434 ng/mL | Geometric Coefficient of Variation 76.8 |
| All Participants | Plasma Concentrations of Triptorelin | Month 6, predose | 0.0251 ng/mL | Geometric Coefficient of Variation 648.7 |
| All Participants | Plasma Concentrations of Triptorelin | Month 6, 4 hours post-injection | 24.7 ng/mL | Geometric Coefficient of Variation 66 |
| All Participants | Plasma Concentrations of Triptorelin | Month 12 | 0.0223 ng/mL | Geometric Coefficient of Variation 110.3 |