UnknownPhase 3

Evaluate the Efficacy and Safety of DWJ108J

South Korea79 participantsStarted 2023-08-01

Plain-language summary

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

Age range4 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. Following conditions at Visit 1(Screening) :
✕. 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
✕. 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:
✕. 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

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.

Timeframe: 6 months

NCT IDNCT06025409

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-28

Yeonseo Choi, MD. PhD

Who can participate

Age range4 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. Following conditions at Visit 1(Screening) :
✕. 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
✕. 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:
✕. 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