Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty (NCT06926933) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
South Korea50 participantsStarted 2024-12-12
Plain-language summary
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP.
Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.
Who can participate
Age range4 Years – 9 Years
SexALL
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Inclusion criteria
✓. Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation \> 5 IU/L
✓. A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older \~ under 9 years of age) Girl (4 years of age or older \~ under 8 years of age) Tanner Stage : Level 2 or higher
✓. Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
✓. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
✓. Children with a body weight of more than 20 kg at screening
✓. Children have a bone age that is ≥1 year older than their chronological age at screening
✓. A signed written consent form by a legal representative who has been informed about this study
Exclusion criteria
✕. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
What they're measuring
1
The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test
✕. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
✕. Prior (within 12 weeks of Screening) use of medications
✕. Prior or current therapy with growth hormone
✕. Major medical or psychiatric illness that could interfere with study visits
✕. Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age)