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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06025409
Other study ID # DW_DWJ108J301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 1, 2023
Est. completion date August 31, 2025

Study information

Verified date August 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact Yeonseo Choi, MD. PhD
Phone 82-2-550-8800
Email yeonseo@daewoong.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 79
Est. completion date August 31, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility Inclusion Criteria: 1. Exhibited pubertal response of LH (peak = 5 IU/L) during GnRH stimulation test at screening 2. Diagnosis of central precocious puberty 3. 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 4. Difference between bone age (Greulich and Pyle method) and chronological age = 1 year 5. In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent Exclusion Criteria: 1. 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 2. requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis 3. Prior treatment with GnRH analogues 4. Hypersensitive to the investigational drug for this clinical trial or GnRH analogues 5. Prior or current therapy with growth hormone 6. 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 7. 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 8. 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Leuprolide Acetate 11.25 MG/ML
Subcutaneous injection

Locations

Country Name City State
Korea, Republic of Ajou University medical center Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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. 3 months
Secondary 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. Baseline, 3 and 6 months
Secondary 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 3 and 6 months
Secondary 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. Baseline, 3 and 6 months
Secondary 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. 6 months
Secondary 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. 6 months
Secondary 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. 6 months
See also
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Completed NCT02993926 - A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
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Completed NCT02427958 - A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants Phase 4
Completed NCT05029622 - A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. Phase 3
Completed NCT01467882 - Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty Phase 3
Recruiting NCT00438217 - Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children Phase 4