Phase 3
N=32
Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
Central Precocious Puberty
Bottom Line
View on ClinicalTrials.gov: NCT04736602 ↗Enrolled (actual)
32
Serious AEs
6.3%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triptorelin pamoate 15mg (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation |
100 | — |
| SECONDARY Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels |
-0.6906; -0.7411; -0.7415; -0.9310; -2.3531; -2.2307 | — |
| SECONDARY Percentage of Participants With LH Suppression After GnRH Stimulation |
93.5; 93.5 | — |
| SECONDARY Change From Baseline in Peak LH and FSH Level After GnRH Stimulation |
-23.0969; -24.3596; -23.7221; -11.2757; -11.2536; -10.4701 | — |
| SECONDARY Percentage of Participants With Prepubertal Levels of Sex Steroids |
100; 96.8; 90.3; 93.5 | — |
| SECONDARY Change From Baseline in Estradiol Levels |
-8.0047; -8.3011; -7.7458; -8.6204 | — |
| SECONDARY Change From Baseline in Testosterone Levels |
-1.3650; -1.3650; -1.3650; -1.3650 | — |
| SECONDARY Percentage of Participants With Change From Baseline in Pubertal Stage |
35.7; 57.1; 3.6; 3.6; 33.3; 66.7 | — |
| SECONDARY Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline |
92.9; 100; 96.4; 100; 89.3; 100 | — |
| SECONDARY Change From Baseline in Auxological Parameter: Height |
2.24; 3.55; 4.63; 6.54 | — |
| SECONDARY Change From Baseline in Auxological Parameter: Weight |
1.284; 2.533; 3.290; 4.818 | — |
| SECONDARY Change From Baseline in Auxological Parameter: Growth Velocity |
-0.895; -3.769; -4.804; -2.052 | — |
| SECONDARY Change From Baseline in Auxological Parameter: Body Mass Index (BMI) |
0.142; 0.470; 0.585; 0.895 | — |
| SECONDARY Change From Baseline in Bone Age (BA) |
0.233; 0.586 | — |
| SECONDARY Change From Baseline Difference Between BA and Chronological Age (CA) |
-0.44; -0.48 | — |
| SECONDARY Change From Baseline in Uterine Length |
-0.4012; -0.3771 | — |
| SECONDARY Change From Baseline of Testicular Volume |
-2.4022; -4.7334; -2.8840; -6.7975 | — |
Summary
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04736602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.