Hormone blocker aims to pause early puberty in children

NCT ID NCT06926933

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

4 to 9 years

Sex

Anyone

Healthy volunteers

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

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

  • Ajou University Medical Center

    Suwon, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • Chosun University Hospital

    Kwangju, South Korea

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Jeonbuk National University Hospital

    Jeonju, South Korea

  • Kangdong Sacred Heart Hospital

    Seoul, South Korea

  • Korea University Ansan Hospital

    Ansan, South Korea

  • Kyung Hee University Hospital At Gangdong

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

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