Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Twice-Yearly shot could halt early puberty in kids

NCT ID NCT05493709

Disease control Sponsor: Foresee Pharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This phase 3 trial tests a new formulation of leuprolide (FP-001) given as two injections six months apart in 93 children with central precocious puberty—a condition where puberty starts too early. The goal is to see if it can safely pause puberty by keeping hormone levels low. If it works, it could mean fewer injections for children needing treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Leuprolide (a hormone blocker)
What this could lead to
If successful, this could provide a treatment that pauses early puberty with just two injections per year, reducing the need for more frequent shots.
What could go wrong
This is a single-arm, open-label study with no placebo group, so results may be less definitive. The treatment is not a cure—it only delays puberty while active, and long-term effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

94 people

The number who actually took part.

Started

Jun 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 9 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Puberty; precocious, central are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

central precocious puberty precocious puberty

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Puberty; precocious, central

Contacts and locations

Locations

  • Arizona University

    Tucson, Arizona, 85719, United States

  • Beijing Children's Hospital, Capital Medical University

    Beijing, China

  • Chang Gung Memorial Hospital-Kaohsiung branch

    Kaohsiung City, 704302, Taiwan

  • Changhua Christian Hospital

    Changhua, 50006, Taiwan

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, China

  • Children's Hospital affiliated to Capital Institute of Pediatrics

    Beijing, Chaoyang District, China

  • Children's Hospital of Fudan University

    Shanghai, China

  • Children's Hospital of Shanghai

    Shanghai, China

  • Children's Hospital of Shanxi

    Taiyuan, Shanxi, China

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu, China

  • China Medical University Hospital

    Taichung, Taiwan

  • Cook Children's

    Fort Worth, Texas, 76104, United States

  • Hunan Children's Hospital

    Changsha, Hunan, China

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, China

  • Johns Hopkins - All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • LinKou Chang-Gung Memorial Hospital (CGMH-LK)

    Taoyuan City, 333423, Taiwan

  • Mackay Memorial Hospital

    Taipei, 104217, Taiwan

  • Multicare Health System

    Tacoma, Washington, 98405, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Nemours Children's Health Center

    Jacksonville, Florida, 32207, United States

  • Ningbo Women & Children's Hospital

    Ningbo, Zhejiang, China

  • Pearl River Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • Rady Children's Hospital- San Diego

    San Diego, California, 92123, United States

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404, United States

  • Shanghai Children's Medical Center

    Shanghai, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, China

  • The Children&#39;s Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, China

  • The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University

    Jiaxing, Zhejiang, China

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, China

  • The first Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, 430030, China

  • University Pediatric Hospital

    San Juan, 00935, Puerto Rico

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Virginia University

    Charlottesville, Virginia, 22908, United States

  • Wuhan Children's Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, China