Twice-Yearly shot could halt early puberty in kids

NCT ID NCT05493709

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

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.

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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'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