Actively Recruiting
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
Led by HanAll BioPharma Co., Ltd. · Updated on 2025-04-15
50
Participants Needed
9
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP. Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.
CONDITIONS
Official Title
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation > 5 IU/L
- Diagnosis of central precocious puberty with age: boys 4 to under 9 years, girls 4 to under 8 years
- Tanner stage 2 or higher
- Age under 10 years for boys and under 9 years for girls at baseline visit (Day 0)
- Confirmed diagnosis of CPP within 12 months of baseline visit without prior GnRH agonist treatment
- Body weight over 20 kg at screening
- Bone age at least 1 year older than chronological age at screening
- Signed written consent by a legal representative informed about the study
You will not qualify if you...
- Gonadotropin-independent (peripheral) precocious puberty
- Prior or current GnRH treatment for CPP
- Non-progressing isolated premature thelarche
- Unstable intracranial tumor or tumors requiring neurosurgery or cerebral irradiation
- Use of hormonal agonists, antagonists, steroids (except mild topical), or herbal medicines within 12 weeks before screening
- Prior or current growth hormone therapy
- Major medical or psychiatric illness interfering with study visits
- Diagnosis of short stature (2 SD below mean height or below 3rd percentile for age)
- Pregnant or likely pregnant women, nursing women
- Known hypersensitivity to GnRH or related compounds
- Other serious medical conditions or illnesses that may affect participation
- Conditions interfering with protocol compliance
- Treatment with investigational products within 5 half-lives prior to baseline
- History of seizures, epilepsy, or central nervous system disorders associated with seizures
- Use of medications associated with seizures within 6 months prior to baseline or current use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
2
Jeonbuk National University Hospital
Jeonju, South Korea
Actively Recruiting
3
Chosun University Hospital
Kwangju, South Korea
Actively Recruiting
4
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
5
Asan Medical Center
Seoul, South Korea
Actively Recruiting
6
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
7
Kangdong Sacred Heart Hospital
Seoul, South Korea
Actively Recruiting
8
Kyung Hee University Hospital At Gangdong
Seoul, South Korea
Actively Recruiting
9
Ajou University Medical Center
Suwon, South Korea
Actively Recruiting
Research Team
S
Sunmi Park
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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