Central Precocious PubertyPhase 4NCT07710430
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
A Phase 4 study testing Leuprorelin in people with Central Precocious Puberty, run by LG Chem at 1 site in South Korea.
Trial summary
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Central Precocious Puberty
- What is being tested?
- Leuprorelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2026to 30 Apr 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Tanner stage =>2
- Girls younger than 9 years old, boys younger than 10 years old
- Subjects who are diagnosed with central precocious puberty (CPP)
Who cannot join
- GnRH-independent precocious puberty, incomplete precocious puberty, progressive brain tumors, pituitary adenoma
- Hepatic impairment or abnormal liver function tests at screening
- Renal impairment or abnormal renal function at screening
- Use of following within 8 weeks prior to screening or during the study: medications affecting gonadotropin or sex hormone, systemic steroids, herbal medications
- Use of medications associated with seizures
- Requirement for treatments affecting the hypothalamic-pituitary-gonadal axis
- History of seizures, epilepsy, cerebrovascular disease, or central nervous system disorders/tumors
- Known or suspected malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kangdong Sacred Heart Hospital
Seoul
About this study
Official title: A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children With Central Precocious Puberty
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty
- Conditions
- Central Precocious Puberty
- Being tested
- Leuprorelin
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprorelinDrug
Leuprorelin will be administered every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Leuprorelin | Experimental | Not described Receives: Drug: Leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
Measured: 24 weeks after treatment initiation
Secondary outcomes (6)
Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk
Measured: 48 weeks and 96 weeks after treatment initiation
Changes from baseline in endocrine function: basal LH in IU/L, follicle-stimulating hormone (FSH) in IU/L, testosterone (T) in nanograms per deciliter (ng/dL), estradiol (E2) in picograms per milliliter (pg/mL)
Measured: Up to 96 weeks after treatment initiation
Changes from baseline in pubertal development: Tanner stage
Measured: Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: height in centimeter
Measured: Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: weight in kilograms
Measured: Up to 96 weeks after treatment initiation
Safety: Number of participants with treatment-related adverse events as assessed by the investigator
Measured: Up to 96 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710430
- Sponsor's protocol ID
- LG-LPLCL001
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children With Central Precocious Puberty
- ClinicalTrials.gov ID
- NCT07710430
- Acronym / sponsor ID
- LG-LPLCL001
- Conditions
- Central Precocious Puberty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprorelin | Experimental | Drug: Leuprorelin |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Tanner stage =>2
- Girls younger than 9 years old, boys younger than 10 years old
- Subjects who are diagnosed with central precocious puberty (CPP)
Key exclusion criteria (8 listed)
- GnRH-independent precocious puberty, incomplete precocious puberty, progressive brain tumors, pituitary adenoma
- Hepatic impairment or abnormal liver function tests at screening
- Renal impairment or abnormal renal function at screening
- Use of following within 8 weeks prior to screening or during the study: medications affecting gonadotropin or sex hormone, systemic steroids, herbal medications
- Use of medications associated with seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeuprorelinLeuprorelin will be administered every 4 weeks. | Drug | Leuprorelin |
Primary outcome
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
Time frame: 24 weeks after treatment initiation
6 secondary outcomes
Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk
Time frame: 48 weeks and 96 weeks after treatment initiation
Changes from baseline in endocrine function: basal LH in IU/L, follicle-stimulating hormone (FSH) in IU/L, testosterone (T) in nanograms per deciliter (ng/dL), estradiol (E2) in picograms per milliliter (pg/mL)
Time frame: Up to 96 weeks after treatment initiation
Changes from baseline in pubertal development: Tanner stage
Time frame: Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: height in centimeter
Time frame: Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: weight in kilograms
Time frame: Up to 96 weeks after treatment initiation
Safety: Number of participants with treatment-related adverse events as assessed by the investigator
Time frame: Up to 96 weeks after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Central Precocious Puberty
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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
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INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty
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Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)
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CPP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leuprorelin in people with Central Precocious Puberty, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Lead (02-6987-4151, lgclinical@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L). (time frame: 24 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.