Twice-Yearly shot could halt early puberty in kids
NCT ID NCT05493709
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Arizona University
Tucson, Arizona, 85719, United States
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Beijing Children's Hospital, Capital Medical University
Beijing, China
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Chang Gung Memorial Hospital-Kaohsiung branch
Kaohsiung City, 704302, Taiwan
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Changhua Christian Hospital
Changhua, 50006, Taiwan
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Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
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Children's Hospital affiliated to Capital Institute of Pediatrics
Beijing, Chaoyang District, China
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Children's Hospital of Fudan University
Shanghai, China
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Children's Hospital of Shanghai
Shanghai, China
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Children's Hospital of Shanxi
Taiyuan, Shanxi, China
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Children's Hospital of Soochow University
Suzhou, Jiangsu, China
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China Medical University Hospital
Taichung, Taiwan
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Cook Children's
Fort Worth, Texas, 76104, United States
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Hunan Children's Hospital
Changsha, Hunan, China
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Indiana University
Indianapolis, Indiana, 46202, United States
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Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
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Johns Hopkins - All Children's Hospital
St. Petersburg, Florida, 33701, United States
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LinKou Chang-Gung Memorial Hospital (CGMH-LK)
Taoyuan City, 333423, Taiwan
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Mackay Memorial Hospital
Taipei, 104217, Taiwan
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Multicare Health System
Tacoma, Washington, 98405, United States
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National Cheng Kung University Hospital
Tainan, Taiwan
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Nemours Children's Health Center
Jacksonville, Florida, 32207, United States
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Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
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Pearl River Hospital, Southern Medical University
Guangzhou, Guangdong, China
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Rady Children's Hospital- San Diego
San Diego, California, 92123, United States
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Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
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Shanghai Children's Medical Center
Shanghai, China
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Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
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The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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The First Bethune Hospital of Jilin University
Changchun, Jilin, China
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The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
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The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
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The first Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
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Tianjin Medical University General Hospital
Tianjin, China
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Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
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University Pediatric Hospital
San Juan, 00935, Puerto Rico
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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Virginia University
Charlottesville, Virginia, 22908, United States
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Wuhan Children's Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China