Hormone blocker aims to pause early puberty in children
NCT ID NCT06926933
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This trial tests a long-acting injection of leuprolide acetate in children with central precocious puberty, a condition where puberty starts too early. The goal is to suppress puberty-related hormones, slowing or stopping early development. The study includes children aged 4 to 9 (girls) or 4 to 10 (boys) who have not yet received treatment. Researchers will measure hormone levels to see if the drug works and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- leuprolide acetate
- What this could lead to
- If successful, this could provide a safe and effective way to pause early puberty in children, allowing them to grow at a normal pace.
- What could go wrong
- This is a small, single-group study, so results may not apply to all children. The drug may cause side effects like injection site reactions or temporary hormone changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 9 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation \> 5 IU/L 2. 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 3. Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls 4. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP 5. Children with a body weight of more than 20 kg at screening 6. Children have a bone age that is ≥1 year older than their chronological age at screening 7. A signed written consent form by a legal representative who has been informed about this study Exclusion Criteria: 1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion 2. Prior or current GnRH treatment for CPP 3. Non-progressing isolated premature thelarche 4. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible. 5. Prior (within 12 weeks of Screening) use of medications * Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.) * Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents) * Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days) * Herbal Medicines 6. Prior or current therapy with growth hormone 7. Major medical or psychiatric illness that could interfere with study visits 8. Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age) 9. Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women 10. Known hypersensitivity to GnRH or related compounds 11. Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study 12. Any other condition(s) which could significantly interfere with Protocol compliance 13. Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0) 14. Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions 15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per investigator opinion, have been associated with seizures or convulsions
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ajou University Medical Center
Suwon, South Korea
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Asan Medical Center
Seoul, South Korea
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Chosun University Hospital
Kwangju, South Korea
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Gangnam Severance Hospital
Seoul, South Korea
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Jeonbuk National University Hospital
Jeonju, South Korea
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Kangdong Sacred Heart Hospital
Seoul, South Korea
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Korea University Ansan Hospital
Ansan, South Korea
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Kyung Hee University Hospital At Gangdong
Seoul, South Korea
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Seoul National University Bundang Hospital
Seongnam, South Korea
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