Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

June 2, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

June 30, 2026

Conditions
Puberty; Precocious, Central
Interventions
DRUG

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).

Trial Locations (41)

22908

Virginia University, Charlottesville

32207

Nemours Children's Health Center, Jacksonville

33701

Johns Hopkins - All Children's Hospital, St. Petersburg

46202

Indiana University, Indianapolis

50006

Changhua Christian Hospital, Changhua

75390

University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's, Fort Worth

83404

Rocky Mountain Clinical Research, Idaho Falls

85719

Arizona University, Tucson

92123

Rady Children's Hospital- San Diego, San Diego

98405

Multicare Health System, Tacoma

104217

Mackay Memorial Hospital, Taipei

333423

LinKou Chang-Gung Memorial Hospital (CGMH-LK), Taoyuan

430030

Tongji Hospital, Tongji Medical College of HUST, Wuhan

704302

Chang Gung Memorial Hospital-Kaohsiung branch, Kaohsiung City

Unknown

The Second Hospital of Anhui Medical University, Hefei

Children's Hospital affiliated to Capital Institute of Pediatrics, Beijing

The first Affiliated Hospital of Xiamen University, Xiamen

Pearl River Hospital, Southern Medical University, Guangzhou

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

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou

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

Hunan Children's Hospital, Changsha

Children's Hospital of Soochow University, Suzhou

Jiangxi Provincial Children's Hospital, Nanchang

The First Bethune Hospital of Jilin University, Changchun

Shengjing Hospital of China Medical University, Shenyang

Children's Hospital of Shanxi, Taiyuan

Chengdu Women's and Children's Central Hospital, Chengdu

The Children's Hospital, Zhejiang University School of Medicine, Hangzhou

The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University, Jiaxing

Ningbo Women & Children's Hospital, Ningbo

Beijing Children's Hospital, Capital Medical University, Beijing

Children's Hospital of Fudan University, Shanghai

Children's Hospital of Shanghai, Shanghai

Shanghai Children's Medical Center, Shanghai

Tianjin Medical University General Hospital, Tianjin

China Medical University Hospital, Taichung

National Cheng Kung University Hospital, Tainan City

00935

University Pediatric Hospital, San Juan

All Listed Sponsors
collaborator

QPS Holdings LLC

INDUSTRY

collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

lead

Foresee Pharmaceuticals Co., Ltd.

INDUSTRY

NCT05493709 - Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty | Biotech Hunter | Biotech Hunter