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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

NCTNCT05029622 (opens ClinicalTrials.gov in a new tab)Other idD-CN-52014-244Other id2022-003857-78
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
66 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
10 Aug 2021
Primary completion
21 Aug 2022
Completion
13 Feb 2023
First posted
31 Aug 2021
Last update posted
19 Feb 2025
Conditions
Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 3

    A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

    NCT05029622

    10 Aug 2021 to 13 Feb 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 PamoateDrug

Arms1

  • Experimental

    Triptorelin formulation for Intramuscular injection (IM).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Luteinising Hormone (LH) Suppression

    Time frame · At Month 6

    Registry description

    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 outcomes(16)

  1. Percentage of Participants With LH Response to GnRH Test

    Time frame · At Months 3 and 12

    Registry 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.

  2. Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels

    Time frame · Baseline and at Months 3, 6, 9 and 12

    Registry 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.

  3. Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test

    Time frame · Baseline and at Months 3, 6 and 12

    Registry 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).

  4. Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12

    Time frame · Month 6 to Month 12

    Registry 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.

  5. Percentage of Participants With Prepubertal Levels of Sex Steroids

    Time frame · At Months 3, 6, 9 and 12

    Registry 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)/ 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.

  6. Change From Baseline in Mean Height for Age (Z-Score)

    Time frame · Baseline and at Months 6 and 12

    Registry 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.

  7. Change From Baseline in Percentile for Height for Age

    Time frame · Baseline and at Months 6 and 12

    Registry 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.

  8. Change From Baseline in Growth Velocity

    Time frame · Baseline and at Months 6 and 12

    Registry 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.

  9. Percentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not Risen

    Time frame · At Months 6 and 12

    Registry 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.

  10. Change From Baseline in BA:CA Ratio

    Time frame · Baseline, Months 6 and 12

    Registry 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.

  11. Percentage of Participants With Stabilized Pubertal Stage

    Time frame · At Months 6 and 12

    Registry description

    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.

  12. Percentage of Participants With Regression of Uterine Length

    Time frame · At Months 6 and 12

    Registry 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.

  13. Percentage of Participants With Absence of Progression of Testis Volumes

    Time frame · At Months 6 and 12

    Registry 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.

  14. Change From Baseline in Body Mass Index (BMI)

    Time frame · Baseline and at Months 6 and 12

    Registry 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.

  15. Change From Baseline in Weight

    Time frame · Baseline and at Months 6 and 12

    Registry 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.

  16. Plasma Concentrations of Triptorelin

    Time frame · Day 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12

    Registry description

    Blood samples were collected at specified timepoints.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At Month 6

Percentage of Participants With Luteinising Hormone (LH) Suppression

GroupValue (percentage of participants)
All Participants100
Secondary and other outcome results(7)
Secondary outcomeNumber· At Months 3 and 12

Percentage of Participants With LH Response to GnRH Test

GroupValue (percentage of participants)
All Participants97.0
Secondary outcomeMean· Baseline and at Months 3, 6, 9 and 12

Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels

GroupValue (IU/L)Spread
All Participants-1.64202.4287
Secondary outcomeMean· Baseline and at Months 3, 6 and 12

Change From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation Test

GroupValue (IU/L)Spread
All Participants-26.007519.8863
Secondary outcomeNumber· Month 6 to Month 12

Percentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12

GroupValue (percentage of participants)
All Participants98.5
Secondary outcomeNumber· At Months 3, 6, 9 and 12

Percentage of Participants With Prepubertal Levels of Sex Steroids

GroupValue (percentage of participants)
All Participants97.0
Secondary outcomeMean· Baseline and at Months 6 and 12

Change From Baseline in Mean Height for Age (Z-Score)

GroupValue (Z-score)Spread
All Participants0.07340.1433
Secondary outcomeMean· Baseline and at Months 6 and 12

Change From Baseline in Percentile for Height for Age

GroupValue (percentiles of Z-score)Spread
All Participants1.46752.8638

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All ParticipantsParticipants received triptorelin pamoate 22.5 mg IM injection on Day 1.0 / 660 / 6659 / 66

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2024

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.

Yu et al. 2024Advances in therapycited by 3

PMID 39412628PMC11550251DOI 10.1007/s12325-024-02991-xPUB-39412628

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
up to 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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