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Evaluating Leuprolide Mesylate for treating central precocious puberty

An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)

Phase 3 Interventional Foresee Pharmaceuticals Co., Ltd. · NCT05493709

This study is testing if Leuprolide Mesylate can safely help children with central precocious puberty by slowing down their early puberty progression.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment93 (estimated)
Ages2 Years to 9 Years
SexAll
SponsorForesee Pharmaceuticals Co., Ltd. Industry-sponsored
Locations43 sites (Tucson, Arizona and 42 other locations)
Trial IDNCT05493709 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of Leuprolide Mesylate in pediatric patients diagnosed with central precocious puberty. It is a multi-center, open-label, single-arm study where participants will receive two subcutaneous injections of 42 mg Leuprolide six months apart. The study aims to determine the pharmacokinetics of the drug and its impact on the progression of puberty in affected children. All subjects will be monitored for clinical responses and safety throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 2 to 8 years for females and 2 to 9 years for males, diagnosed with central precocious puberty and not previously treated with GnRH analogs.

Not a fit: Patients who have already received GnRH analog treatment for central precocious puberty or those with other underlying conditions affecting puberty may not benefit from this study.

Why it matters

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

How similar studies have performed: Previous studies have shown positive outcomes with GnRH analog therapies for precocious puberty, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive).
2. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP.
3. Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation \> 5 mIU/mL.
4. Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males.
5. Willing and able to participate in the study.
6. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
7. Bone age \< 13 years for girls and \< 14 years for boys.
8. Signed Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form (ICF) by one or both parents (per IRB/IEC requirements), by the custodial parent(s) or by the legal guardian(s) (if required).
9. Signed Assent by patients as per IRB/IEC requirements.

Exclusion Criteria:

1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. This includes true CPP triggered by other conditions, such as congenital adrenal hyperplasia.
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. Patients with hamartomas or adenomas not requiring surgery are eligible.
5. Any other condition, chronic illness or treatment that, in the opinion of the Investigator, may interfere with growth or other study endpoints (e.g., chronic steroid use \[except mild topical steroids\], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
6. Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1).
7. Major medical or psychiatric illness that could interfere with study visits.
8. Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age).
9. Positive urine pregnancy test.
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 patients 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

Tucson, Arizona and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions PubertyPrecocious, Central
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.