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

  • STATUS
    Recruiting
  • End date
    Feb 26, 2022
  • participants needed
    32
  • sponsor
    Ipsen
Updated on 14 April 2021

Summary

The purpose of this study is to observe whether the Triptorelin pamoate 15mg (3-month formulation) effectiveness in Chinese population of CPP children has the same or similar trend with that in overseas CPP population. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection of triptorelin.

Details
Condition Precocious Puberty, Central Precocious Puberty, Testotoxicosis
Treatment Triptorelin pamoate 15mg
Clinical Study IdentifierNCT04736602
SponsorIpsen
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

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

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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