Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty

Completed · Phase 3

Conditions studied: Puberty; Precocious, Central

In brief

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.

Key facts

Study ID

NCT05493709

Run by

Foresee Pharmaceuticals Co., Ltd.

People needed

94

Starts

2023-06-02

Expected to finish

2026-05-24

Last updated by the study team

2026-07-20

Who can join

Age: 2 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive).
• Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP.
• Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation > 5 mIU/mL.
• Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males.
• Willing and able to participate in the study.
• Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
• Bone age < 13 years for girls and < 14 years for boys.
• 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).
• Signed Assent by patients as per IRB/IEC requirements.

You may not qualify if…

• 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.
• Prior or current GnRH treatment for CPP.
• Non-progressing isolated premature thelarche.
• 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.
• 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).
• Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1).
• Major medical or psychiatric illness that could interfere with study visits.
• Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age).
• Positive urine pregnancy test.
• Known hypersensitivity to GnRH or related compounds.
• 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.
• Any other condition(s) which could significantly interfere with Protocol compliance.
• Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0).
• Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions.
• 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 it is running

• Arizona University — Tucson, Arizona, United States
• Rady Children's Hospital- San Diego — San Diego, California, United States
• Nemours Children's Health Center — Jacksonville, Florida, United States
• Johns Hopkins - All Children's Hospital — St. Petersburg, Florida, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cook Children's — Fort Worth, Texas, United States
• Virginia University — Charlottesville, Virginia, United States
• Multicare Health System — Tacoma, Washington, United States
• The Second Hospital of Anhui Medical University — Hefei, Anhui, China
• Children's Hospital affiliated to Capital Institute of Pediatrics — Beijing, Chaoyang District, China
• The first Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Pearl River Hospital, Southern Medical University — Guangzhou, Guangdong, China
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• The Third Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• Tongji Hospital, Tongji Medical College of HUST — Wuhan, Hubei, China
• Wuhan Children's Hospital, Tongji Medical College of HUST — Wuhan, Hubei, China
• Hunan Children's Hospital — Changsha, Hunan, China
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China
• Jiangxi Provincial Children's Hospital — Nanchang, Jiangxi, China
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
• Children's Hospital of Shanxi — Taiyuan, Shanxi, China

Full record on ClinicalTrials.gov

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