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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

NCTNCT04736602 (opens ClinicalTrials.gov in a new tab)Other idD-CN-52014-243
Open at ClinicalTrials.govAsk about this trial

Overview

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

China

Start
27 Mar 2021
Primary completion
9 Feb 2022
Completion
3 Sept 2022
First posted
3 Feb 2021
Last update posted
1 Aug 2024
Conditions
Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 3

    Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

    NCT04736602

    27 Mar 2021 to 3 Sept 2022

Registry summary

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

The purpose of this research was to confirm the effectiveness and safety of the study drug, Triptorelin pamoate 15mg 3-month formulation, in a Chinese population of Central Precocious Puberty (CPP) children.

Interventions

  • Triptorelin pamoate 15mgDrug

Arms1

  • Experimental

    Triptorelin Pamoate 15mg for injection

    Triptorelin was injected at day 1 and month 3. If participants were willing to enter the extension phase, two additional Triptorelin injections were given at month 6 and month 9.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation

    Time frame · At Month 3

    Registry description

    The LH suppression was defined as stimulated peak LH ≤3 International Units/Liter (IU/L). The GnRH stimulation test was performed by using an intravenous (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.

Secondary outcomes(16)

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

    Time frame · Baseline (Day 1) 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 value for LH and FSH levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  2. Percentage of Participants With LH Suppression After GnRH Stimulation

    Time frame · At Months 6 and 12

    Registry description

    A synthetic GnRH (gonadorelin) was used for gonadotrophin stimulation. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) (±5 minutes at each timepoint) after a single IV injection of gonadorelin. A suppressed LH response to GnRH stimulation test was defined as peak LH ≤3 IU/L among the 4 timepoints T0, T30, T60 and T90).

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

    Time frame · Baseline (Day 1) and at Months 3, 6 and 12

    Registry description

    A synthetic GnRH was used for gonadotrophin stimulation. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) (±5 minutes at each timepoint) after a single IV injection of gonadorelin. The FSH response to GnRH stimulation was the peak FSH level among the 4 timepoints (T0, T30, T60 and T90). The LH response to GnRH stimulation test was defined as peak LH ≤3 IU/L among the 4 timepoints T0, T30, T60 and T90). Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  4. 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 ≤0.3 nanogram (ng)/mL in male participants.

  5. Change From Baseline in Estradiol Levels

    Time frame · Baseline (Day 1) and at Months 3, 6 ,9 and 12

    Registry description

    Estradiol serum concentration was analyzed centrally. Change from baseline was defined as the value for estradiol levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  6. Change From Baseline in Testosterone Levels

    Time frame · Baseline (Day 1) and at Months 3, 6 ,9 and 12

    Registry description

    Testosterone serum concentration was analyzed centrally. Change from baseline was defined as the value for testosterone levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  7. Percentage of Participants With Change From Baseline in Pubertal Stage

    Time frame · Baseline (Day 1) and at Months 6 and 12

    Registry 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.

  8. Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline

    Time frame · Baseline (Day 1) and at Months 6 and 12

    Registry 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.

  9. Change From Baseline in Auxological Parameter: Height

    Time frame · Baseline (Day 1) and at Months 3, 6, 9 and 12

    Registry description

    Auxological parameter including height was analyzed. 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 dose administered.

  10. Change From Baseline in Auxological Parameter: Weight

    Time frame · Baseline (Day 1) and at Months 3, 6, 9 and 12

    Registry description

    Auxological parameter including weight was analyzed. 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 dose administered.

  11. Change From Baseline in Auxological Parameter: Growth Velocity

    Time frame · Baseline (Day 1) and at Months 3, 6, 9 and 12

    Registry description

    Auxological parameter including growth velocity was analyzed. 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 dose administered.

  12. Change From Baseline in Auxological Parameter: Body Mass Index (BMI)

    Time frame · Baseline (Day 1) and at Months 3, 6, 9 and 12

    Registry description

    Auxological parameter including BMI was analyzed. 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 dose administered.

  13. Change From Baseline in Bone Age (BA)

    Time frame · Baseline (Day 1) and at Months 6 and 12

    Registry description

    BA was determined using X-rays of the hand and wrist. Change from baseline was defined as the value for BA at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  14. Change From Baseline Difference Between BA and Chronological Age (CA)

    Time frame · Baseline (Day 1) and at Months 6 and 12

    Registry description

    BA was determined using X-rays of the hand and wrist. Change from baseline was defined as the difference between BA and CA value at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  15. Change From Baseline in Uterine Length

    Time frame · Baseline (Day 1) and at Months 6 and12

    Registry description

    Uterine length was determined by type B ultrasound. Change from baseline was defined as the value of uterine length at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

  16. Change From Baseline of Testicular Volume

    Time frame · Baseline (Day 1) and at Months 6 and 12

    Registry description

    Testicular volume was determined by type B ultrasound. Change from baseline was defined as the value of testicular volume at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.

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 3

Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation

GroupValue (percentage of participants)
All Participants100
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (Day 1) and at Months 3, 6, 9 and 12

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

GroupValue (IU/L)Spread
All Participants-0.69061.6417
Secondary outcomeNumber· At Months 6 and 12

Percentage of Participants With LH Suppression After GnRH Stimulation

GroupValue (percentage of participants)
All Participants93.5
Secondary outcomeMean· Baseline (Day 1) and at Months 3, 6 and 12

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

GroupValue (IU/L)Spread
All Participants-23.096917.9856
Secondary outcomeNumber· At Months 3, 6, 9 and 12

Percentage of Participants With Prepubertal Levels of Sex Steroids

GroupValue (percentage of participants)
All Participants100
Secondary outcomeMean· Baseline (Day 1) and at Months 3, 6 ,9 and 12

Change From Baseline in Estradiol Levels

GroupValue (pg/mL)Spread
All Participants-8.004715.6905
Secondary outcomeMean· Baseline (Day 1) and at Months 3, 6 ,9 and 12

Change From Baseline in Testosterone Levels

GroupValue (ng/mL)Spread
All Participants-1.36501.1734
Secondary outcomeNumber· Baseline (Day 1) and at Months 6 and 12

Percentage of Participants With Change From Baseline in Pubertal Stage

GroupValue (percentage of participants)
All Participants35.7

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 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.0 / 322 / 3227 / 32

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

Studies0

Studies that cite this trial.

No study cites this trial.

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: * Onset of development of secondary sex characteristics before 8 and 9 years in girls and boys, respectively breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II * Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥5 IU/L) * Difference between bone age (BA) (according to Greulich and Pyle method) and chronological age (CA) \>1 year * Girls with Tanner staging ≥2 for breast development and enlarged uterine length and several follicles with diameter \>4 mm in the ovary at Screening visit; boys who have testicular volume ≥4 mL at Screening visit * Age \< 9 years old for girls and \< 10 years old for boys at initiation of triptorelin treatment * Weight at least 20 kg * Subjects will qualify for the extension phase if they sign the corresponding specific consent form, are still benefiting from treatment at the end the primary study and have not experienced any unacceptable safety issues. Exclusion Criteria: * Gonadotropin-independent (peripheral) precocious puberty: extra pituitary 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 * Evidence of renal (creatinine \>1.5 x upper limit of normal (ULN)) or hepatic impairment (bilirubin \>1.5 x ULN or alanine aminotransferase (ALT)/aspartate transaminase (AST) \>3 x ULN) * Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use except topical steroids, renal failure, diabetes, moderate to severe scoliosis) * Prior or current therapy with a GnRH agonist (GnRHa), medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1) * Diagnosis of short stature, i.e. \>2.25 standard deviation (SD) below the mean height for age * Major medical or psychiatric illness that could interfere with study visits * Known hypersensitivity to any of the test materials or related compounds * Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.

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