Puberty; Precocious, CentralPhase 3NCT05493709
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
A Phase 3 study testing Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide in people with Puberty; Precocious, Central, run by Foresee Pharmaceuticals Co., Ltd. at 41 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Puberty; Precocious, Central
- What is being tested?
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 41 sitesin 4 countries
- Study dates
- 2 Jun 2023to 24 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
China24 sites
Children's Hospital affiliated to Capital Institute of Pediatrics
Beijing, Chaoyang District
Beijing Children's Hospital, Capital Medical University
Beijing
The First Bethune Hospital of Jilin University
Changchun, Jilin
Hunan Children's Hospital
Changsha, Hunan
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Pearl River Hospital, Southern Medical University
Guangzhou, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Second Hospital of Anhui Medical University
Hefei, Anhui
The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi
Ningbo Women & Children's Hospital
Ningbo, Zhejiang
Children's Hospital of Fudan University
Shanghai
Children's Hospital of Shanghai
Shanghai
Shanghai Children's Medical Center
Shanghai
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Children's Hospital of Soochow University
Suzhou, Jiangsu
Children's Hospital of Shanxi
Taiyuan, Shanxi
Tianjin Medical University General Hospital
Tianjin
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030
Wuhan Children's Hospital, Tongji Medical College of HUST
Wuhan, Hubei
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian
United States10 sites
Virginia University
Charlottesville, Virginia, 22908
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Cook Children's
Fort Worth, Texas, 76104
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Indiana University
Indianapolis, Indiana, 46202
Nemours Children's Health Center
Jacksonville, Florida, 32207
Rady Children's Hospital- San Diego
San Diego, California, 92123
Johns Hopkins - All Children's Hospital
St. Petersburg, Florida, 33701
Multicare Health System
Tacoma, Washington, 98405
Arizona University
Tucson, Arizona, 85719
Taiwan6 sites
Changhua Christian Hospital
Changhua, 50006
Chang Gung Memorial Hospital-Kaohsiung branch
Kaohsiung City, 704302
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Mackay Memorial Hospital
Taipei, 104217
LinKou Chang-Gung Memorial Hospital (CGMH-LK)
Taoyuan City, 333423
About this study
Official title: 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)
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.
Read the detailed description
This is a multi-center, open-label, single-arm study. All subjects will be pediatric patients with central precocious puberty judged to be candidates for GnRH (gonadotropin releasing hormone) analog therapy, and all will receive two injections of FP-001 42 mg six-month apart in an unblinded fashion.
- Conditions
- Puberty; Precocious, Central
- Being tested
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide Mesylate, Subcutaneous injection of 42 mg LeuprolideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| FP-001 42 mg | Experimental | 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). Receives: Drug: Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
The percentage of patients with serum LH concentrations < 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
Measured: 48 weeks
Secondary outcomes (5)
Effect of FP-001 42 mg on bone age progression
Evaluate the changes in bone age progression from the baseline to Weeks 24 and 48 using centralized analysis of wrist x-ray
Measured: 24 and 48 weeks
Effect of FP-001 42 mg on growth rate
Evaluate the changes in growth rate and bone age advancement relative to chronological age from baseline to end of study using height in meters
Measured: 48 weeks
Effect of FP-001 42 mg on physical signs of puberty
Evaluate the change in physical signs of puberty as measure by Tanner stages from baseline to end of study
Measured: 48 weeks
Effect of FP-001 42 mg on suppression of physical signs of puberty
Evaluate the percentage of patients with suppression of physical signs of puberty
Measured: 48 weeks
Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH
Evaluate The proportion of subjects exhibiting "acute-on-chronic" phenomenon (i.e., related to the second dose of FP-001 42 mg)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start2 Jun 2023
- Primary completion7 Dec 2025
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puberty; Precocious, CentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC, Changchun GeneScience Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bassem Elmankabadi, Study director, Foresee Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493709
- Sponsor's protocol ID
- FP-001-CP-001
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05493709
- Acronym / sponsor ID
- FP-001-CP-001
- Conditions
- Puberty; Precocious, Central
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC, Changchun GeneScience Pharmaceutical Co., Ltd.
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 7 Dec 2025 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, open-label, single-arm study. All subjects will be pediatric patients with central precocious puberty judged to be candidates for GnRH (gonadotropin releasing hormone) analog therapy, and all will receive two injections of FP-001 42 mg six-month apart in an unblinded fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FP-001 42 mg | Experimental | Drug: Leuprolide Mesylate, Subcutaneous injection of 42 mg LeuprolideAll 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). |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprolide Mesylate, Subcutaneous injection of 42 mg LeuprolideAll 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). | Drug | FP-001 42 mg |
Primary outcome
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
Time frame: 48 weeks
The percentage of patients with serum LH concentrations < 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
5 secondary outcomes
Effect of FP-001 42 mg on bone age progression
Time frame: 24 and 48 weeks
Effect of FP-001 42 mg on growth rate
Time frame: 48 weeks
Effect of FP-001 42 mg on physical signs of puberty
Time frame: 48 weeks
Effect of FP-001 42 mg on suppression of physical signs of puberty
Time frame: 48 weeks
Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem Elmankabadi study director
Foresee Pharma
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide in people with Puberty; Precocious, Central, run by Foresee Pharmaceuticals Co., Ltd. at 41 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China, United States, Taiwan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Leuprolide Mesylate (FP-001 42 mg) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.