Clinical Trial Results:
A phase III, open-label, multicentre, single arm study to assess the efficacy and safety of the triptorelin 6-month formulation in Chinese paediatric participants with central precocious puberty
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Summary
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EudraCT number |
2022-003857-78 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Feb 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Aug 2023
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First version publication date |
26 Aug 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D-CN-52014-244
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05029622 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Ipsen Pharma
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Sponsor organisation address |
65, quai Georges Gorse, Boulogne Billancourt, France, 92100
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Public contact |
Medical Director, Ipsen Pharma, clinical.trials@ipsen.com
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Scientific contact |
Medical Director, Ipsen Pharma, clinical.trials@ipsen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Feb 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Feb 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study was to assess the efficacy of the triptorelin 6-month prolonged release (PR) formulation in suppressing luteinising hormone (LH) levels to prepubertal levels [defined as a peak LH <=5 international units per liter (IU/L)] after intravenous (IV) GnRH stimulation at Month 6 (Day 169) in Chinese children with central precocious puberty (CPP).
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Protection of trial subjects |
The study was conducted under the provisions of the Declaration of Helsinki, in accordance with the Good Clinical Practice of China and in compliance with ethics committee and informed consent
regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
China: 66
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Worldwide total number of subjects |
66
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
66
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This Phase 3, open-label, single arm, study was conducted in children with CPP at 12 investigational sites in China. | ||||||||||
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Pre-assignment
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Screening 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. | ||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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All Participants | ||||||||||
Arm description |
Participants received triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1 and Month 6 (Day 169). | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Triptorelin pamoate
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Investigational medicinal product code |
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Other name |
Diphereline®
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Pharmaceutical forms |
Powder and solvent for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Triptorelin pamoate was administered as an IM injection of 6 milliliter (mL), containing 22.5 mg dose with release of monthly dose of 3.75 mg over a 169-day period.
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Baseline characteristics reporting groups
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Reporting group title |
All Participants
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Reporting group description |
Participants received triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1 and Month 6 (Day 169). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All Participants
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Reporting group description |
Participants received triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1 and Month 6 (Day 169). | ||
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End point title |
Percentage of Participants With LH Suppression [1] | ||||||||
End point description |
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. The intention-to-treat (ITT) population consisted of all participants who received at least 1 dose of study intervention.
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End point type |
Primary
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End point timeframe |
At Month 6
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No additional statistical analysis was prespecified for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With LH Response to GnRH Test | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
At Months 3 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels | ||||||||||||||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 3, 6, 9 and 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test | ||||||||||||||||||||
End point description |
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). The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 3, 6 and 12
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12 | ||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.
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End point type |
Secondary
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End point timeframe |
Month 6 to Month 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With Prepubertal Levels of Sex Steroids | ||||||||||||||||
End point description |
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)/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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
At Months 3, 6, 9 and 12
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change From Baseline in Mean Height for Age (Z-Score) | ||||||||||||
End point description |
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. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Percentile for Height for Age | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Growth Velocity | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio not Risen | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
At Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in BA:CA Ratio | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With Stabilized Pubertal Stage | ||||||||||||||||||||||||
End point description |
Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital stage in male participants, breast stage in female participants and pubic hair 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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point. Breast development stage (BDS), Genital development stage (GDS), Pubic hair development (PHD), Month 6 (M6), Month 12 (M12).
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End point type |
Secondary
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End point timeframe |
At Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants With Regression of Uterine Length | ||||||||||||
End point description |
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. 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. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
At Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With Absence of Progression of Testis Volumes | ||||||||||||
End point description |
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. 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.
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End point type |
Secondary
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End point timeframe |
At Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Body Mass Index (BMI) | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Weight | ||||||||||||
End point description |
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. The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline and at Months 6 and 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Plasma Concentrations of Triptorelin | ||||||||||||||||||
End point description |
Blood samples were collected at specified timepoints. 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. Here, ‘n’ = number of participants analyzed at specific time point.
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End point type |
Secondary
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End point timeframe |
Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to a maximum of approximately 344 days.
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Adverse event reporting additional description |
Safety population consisted of all participants who received at least 1 dose of study treatment and have at least 1 post-baseline safety assessment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
All Participants
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Reporting group description |
Participants received triptorelin pamoate 22.5 mg IM injection on Day 1 and Month 6 (Day 169). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Apr 2022 |
Schedule of activities updated according to the actual situation and clarified the time of clinical laboratory examination and BMI measurement time. A new text was added to benefit/risk assessment as per new template version. Adjustment of blood collection volume was updated according to the actual situation in scientific rationale for study design and section 8. Clarified the inclusion criteria minimum number of follicles larger than 4 millimeter in diameter. The amount of blood to be collected was updated according to the actual situation and typo corrected and relevant description added in PK section. In Appendix 2 section adjusted table superscript and adjusted description of note. Adjusted the description of “report of suspected or confirmed coronavirus disease 2019 infection and updated serious adverse events report requirement as per new protocol template. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
