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 range
4 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test
. 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
. Prior or current GnRH treatment for CPP
. Non-progressing isolated premature thelarche
. 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)