Evaluating leuprolide acetate for treating central precocious puberty

An Open Label, Single-group, Multicenter Study on the Efficacy and Safety of Leuprolide Acetate 45 mg for Injectable Suspension-controlled Release in Subjects With Central (Gonadotropin-dependent) Precocious Puberty

This study is testing if a medication called leuprolide acetate can help children with central precocious puberty feel better and manage their symptoms.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 4 Years to 9 Years
• Sex: All
• Sponsor: HanAll BioPharma Co., Ltd. (industry)
• Locations: 9 sites (Ansan and 8 other locations)
• Trial ID: NCT06926933 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, single-group phase 4 study aims to assess the efficacy and safety of a 45 mg dose of leuprolide acetate in pediatric patients diagnosed with central precocious puberty (CPP). Participants will undergo screening tests, including a GnRH stimulation test, to confirm their CPP diagnosis before treatment initiation. The study focuses on children who have not previously received GnRH agonist treatment and meet specific inclusion criteria related to age, weight, and bone age. The goal is to determine how well this treatment works in managing CPP symptoms.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 4 to under 9 years for boys and 4 to under 8 years for girls, diagnosed with CPP and not previously treated with GnRH agonists.

Not a fit: Patients with gonadotropin-independent precocious puberty or those who do not meet the specific age and diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could effectively manage and mitigate the symptoms of central precocious puberty in affected children.

How similar studies have performed: Other studies have shown success with GnRH agonist treatments for CPP, indicating that this approach is well-established in the field.

Eligibility criteria

Inclusion Criteria:

1. Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation \> 5 IU/L
2. A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older \~ under 9 years of age) Girl (4 years of age or older \~ under 8 years of age) Tanner Stage : Level 2 or higher
3. Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
4. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
5. Children with a body weight of more than 20 kg at screening
6. Children have a bone age that is ≥1 year older than their chronological age at screening
7. A signed written consent form by a legal representative who has been informed about this study

Exclusion Criteria:

1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
2. Prior or current GnRH treatment for CPP
3. Non-progressing isolated premature thelarche
4. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
5. Prior (within 12 weeks of Screening) use of medications

   * Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.)
   * Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents)
   * Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days)
   * Herbal Medicines
6. Prior or current therapy with growth hormone
7. Major medical or psychiatric illness that could interfere with study visits
8. Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age)
9. Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women
10. Known hypersensitivity to GnRH or related compounds
11. 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
12. Any other condition(s) which could significantly interfere with Protocol compliance
13. Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0)
14. Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per investigator opinion, have been associated with seizures or convulsions

Where this trial is running

Ansan and 8 other locations

• Korea University Ansan Hospital — Ansan, South Korea (RECRUITING)
• Jeonbuk National University Hospital — Jeonju, South Korea (RECRUITING)
• Chosun University Hospital — Kwangju, South Korea (RECRUITING)
• Seoul National University Bundang Hospital — Seongnam, South Korea (RECRUITING)
• Asan Medical Center — Seoul, South Korea (RECRUITING)
• Gangnam Severance Hospital — Seoul, South Korea (RECRUITING)
• Kangdong Sacred Heart Hospital — Seoul, South Korea (RECRUITING)
• Kyung Hee University Hospital At Gangdong — Seoul, South Korea (RECRUITING)
• Ajou University Medical Center — Suwon, South Korea (RECRUITING)

Study contacts

• Study coordinator: Sunmi Park

Conditions: CPP