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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003857-78 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin formulation for Intramuscular injection (IM). | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin Pamoate | Drug | Triptorelin 6-month formulation for IM on day 1 and Month 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | 100045 | China | |||
| No.1 Hospital of Jilin University (Bethune first hospital of Jilin University) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39412628 | Derived | Yu X, Cheng X, Wei H, Xu X, Gong C, Li G, Yao H, Zhou L, Zhong Y, Yang Y, Luo F, Zhang Y, Huang F, Shi X, Cabri P, Luo X. A Phase 3, Open-Label, Single-Arm Trial of the Efficacy and Safety of Triptorelin 6-Month Formulation in Chinese Children with Central Precocious Puberty. Adv Ther. 2024 Dec;41(12):4537-4556. doi: 10.1007/s12325-024-02991-x. Epub 2024 Oct 16. |
| Label | URL |
|---|---|
| Lay language results summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received triptorelin pamoate 22.5 milligrams (mg) intramuscular (IM) injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2022 | Nov 16, 2023 |
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| At Months 3 and 12 |
| 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. | Baseline and at Months 3, 6, 9 and 12 |
| 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). | Baseline and at Months 3, 6 and 12 |
| 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. | Month 6 to Month 12 |
| 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. | At Months 3, 6, 9 and 12 |
| 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. | Baseline and at Months 6 and 12 |
| 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. | Baseline and at Months 6 and 12 |
| 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. | Baseline and at Months 6 and 12 |
| 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. | At Months 6 and 12 |
| 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. | Baseline, Months 6 and 12 |
| 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. | At Months 6 and 12 |
| 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. | At Months 6 and 12 |
| 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. | At Months 6 and 12 |
| 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. | Baseline and at Months 6 and 12 |
| 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. | Baseline and at Months 6 and 12 |
| Plasma Concentrations of Triptorelin | Blood samples were collected at specified timepoints. | Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12 |
| Changchun |
| 130021 |
| China |
| Children's Hospital of Fudan University | Changhai | 201102 | China |
| Hunan children's hospital | Changsha | 410007 | China |
| Chengdu Women's & Children's Central Hospital | Chengdu | 610073 | China |
| Shandong Provincial Hospital | Jinan | 250021 | China |
| Linyi Maternal and Child Health Care Hospital | Linyi | 276016 | China |
| Jiangxi Provincial Children's Hospital | Nanchang | 330006 | China |
| Pingxiang Maternity and Child Care | Pingxiang | 337000 | China |
| Children's Hospital of Soochow University | Suzhou | 215031 | China |
| Wuhan Children's Hospital Tongji Medical College Huazhong University of Science & Technology | Wuhan | 430015 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | 430030 | China |
| Wuxi children's Hospital | Wuxi | 214023 | China |
| Zhengzhou Children's Hospital , Henan Children's Hospital | Zhengzhou | 450018 | China |
| COMPLETED |
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| NOT COMPLETED |
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|
The intention-to-treat (ITT) population consisted of all participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received triptorelin pamoate 22.5 mg IM injection on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | At Month 6 |
|
|
| |||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 3 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | IU/L | Baseline and at Months 3, 6, 9 and 12 |
|
| ||||||||||||||||||||||||||
| 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). | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | IU/L | Baseline and at Months 3, 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 to Month 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 3, 6, 9 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | Z-score | Baseline and at Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | percentiles of Z-score | Baseline and at Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | centimeter (cm)/year | Baseline and at Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | ratio | Baseline, Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
| ||||||||||||||||||||||||||
| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | kilogram (kg)/meter square | Baseline and at Months 6 and 12 |
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| 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. | The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported. | Posted | Mean | Standard Deviation | kg | Baseline and at Months 6 and 12 |
|
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| Secondary | Plasma Concentrations of Triptorelin | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12 |
|
|
Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to a maximum of approximately 344 days.
The Safety population consisted of all participants who received at least 1 dose of study treatment and have at least 1 post-baseline safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants received triptorelin pamoate 22.5 mg IM injection on Day 1. | 0 | 66 | 0 | 66 | 59 | 66 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nocturnal emission | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Myoglobin blood increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Refraction disorder | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | see email | clinical.trials@ipsen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2023 | Nov 16, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
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