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New injection slows down early puberty in kids

NCT ID NCT05341115

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tested a drug called leuprorelin to control central precocious puberty, a condition where children start puberty too early. About 80 children received an injection every 12 weeks for 6 months. The goal was to suppress hormones that drive early puberty, helping children develop at a more normal pace.

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

79 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2025

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

Up to 10 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. Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years 2. Body weight ≥20 kg 3. According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level \>5.0 IU/L with LH/FSH \>0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening. Exclusion Criteria: 1. The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent. 2. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease. 3. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound. 4. The participant has a diagnosis of peripheral precocious puberty.

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Conditions

The condition(s) this trial relates to.

central precocious puberty precocious puberty

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central precocious puberty

Contacts and locations

Locations

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100033, China

  • Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021, China

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality, 200062, China

  • The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University.

    Wuhan, Hubei, 430030, China

  • the First A liated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510062, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.