Central Precocious PubertyPhase 3NCT06025409
Evaluate the Efficacy and Safety of DWJ108J
A Phase 3 study testing Leuprolide Acetate 11.25 MG/ML in people with Central Precocious Puberty, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Central Precocious Puberty
- What is being tested?
- Leuprolide Acetate 11.25 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2023to 31 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
- Diagnosis of central precocious puberty
- For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above
- Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
- In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent
Who cannot join
- Following conditions at Visit 1(Screening) :
- Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma
- requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
- Prior treatment with GnRH analogues
- Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
- Prior or current therapy with growth hormone
Show all 10Show fewer
- has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine
- Meets the following criteria based on screening test results:
- AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University medical center
Gyeonggi-do
Jin Soon Hwang, 82-1688-6114, yeonseo@daewoong.co.kr
About this study
Official title: A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study
This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.
Read the detailed description
The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.
- Conditions
- Central Precocious Puberty
- Being tested
- Leuprolide Acetate 11.25 MG/ML
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide Acetate 11.25 MG/MLDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Leuprorelin | Experimental | Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months. Receives: Drug: Leuprolide Acetate 11.25 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Measured: 6 months
Secondary outcomes (7)
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Measured: 3 months
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Measured: Baseline, 3 and 6 months
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Measured: 3 and 6 months
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Measured: Baseline, 3 and 6 months
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Measured: 6 months
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Measured: 6 months
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Aug 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Aug 2025 (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.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Soong Hwang, MD. PhD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025409
- Sponsor's protocol ID
- DW_DWJ108J301
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study
- ClinicalTrials.gov ID
- NCT06025409
- Acronym / sponsor ID
- DW_DWJ108J301
- Conditions
- Central Precocious Puberty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Sep 2023 (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.
This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.
Detailed description
The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early 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 |
|---|---|---|
| Experimental: Leuprorelin | Experimental | Drug: Leuprolide Acetate 11.25 MG/MLParticipants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
- Diagnosis of central precocious puberty
- For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above
- Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
- In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent
Key exclusion criteria (10 listed)
- Following conditions at Visit 1(Screening) :
- Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma
- requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
- Prior treatment with GnRH analogues
- Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
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 |
|---|---|---|
| Leuprolide Acetate 11.25 MG/MLSubcutaneous injection | Drug | Experimental: Leuprorelin |
Primary outcome
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
Time frame: 6 months
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
7 secondary outcomes
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
Time frame: 3 months
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Time frame: Baseline, 3 and 6 months
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Time frame: 3 and 6 months
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Time frame: Baseline, 3 and 6 months
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Time frame: 6 months
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Time frame: 6 months
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jin Soong Hwang, MD. PhD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprolide Acetate 11.25 MG/ML in people with Central Precocious Puberty, run by Daewoong Pharmaceutical Co. LTD. 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeonseo Choi, MD. PhD (82-2-550-8800, yeonseo@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. (time frame: 6 months). 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 6 Sep 2023.