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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-27

Study Completion Date

2022-09-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Central Precocious Puberty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Triptorelin pamoate 15mg

Intervention Type DRUG

Intramuscular injection (IM)

Interventions

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Triptorelin pamoate 15mg

Intramuscular injection (IM)

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No