Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
NCT ID: NCT05493709
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
93 participants
INTERVENTIONAL
2023-06-02
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FP-001 42 mg
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).
Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).
Interventions
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Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
9 Years
ALL
No
Sponsors
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QPS Holdings LLC
INDUSTRY
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Foresee Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bassem Elmankabadi
Role: STUDY_DIRECTOR
Foresee Pharma
Locations
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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
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Children's Hospital of Fudan University
Shanghai, , China
Children's Hospital of Shanghai
Shanghai, , China
Shanghai Children's Medical Center
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
University Pediatric Hospital
San Juan, , Puerto Rico
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital-Kaohsiung branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
LinKou Chang-Gung Memorial Hospital (CGMH-LK)
Taoyuan, , Taiwan
Countries
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Other Identifiers
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FP-001-CP-001
Identifier Type: -
Identifier Source: org_study_id
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