To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Follicle-stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection in Idiopathic Hypogonadotropin Hypogonadism

This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Hypogonadotropic Hypogonadism
• Intervention / Treatment: Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection; Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo

Detailed Description

A multicenter, randomized, double-blind, Phase III clinical study to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection to initiate or restore puberty in idiopathic hypogonadotropin hypogonadism in adolescent males aged 14 to 18 years.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: lingling Li; Phone Number: +86-18826108784; Email: lilingling01@genscigroup.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Anhui Children's Hospital
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, Capital Medical University
    • Beijing, Beijing, China, 100730
      • Peking Union Hospital, Chinese Academy of Medical Sciences
      • Contact: xueyan Wu, Doctor of Medicine; Phone Number: 010-69154116; Email: wsheyan@vip.sina.com
  • Guangdong
    • GuangZhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510623
      • Women and Children's Medical Center Affiliated to Guangzhou Medical University
    • Shenzhen, Guangdong, China, 518026
      • Shenzhen Children's Hospital
  • Henan
    • Zhengzhou, Henan, China, 450018
      • Henan Children's Hospital Zhengzhou Children's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210093
      • Nanjing Children's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330200
      • Jiangxi Children's Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital affiliated to China Medical University
  • Shangdong
    • Jining, Shangdong, China, 272100
      • Affiliated Hospital of Jining Medical College
  • Shanghai
    • ShangHai, Shanghai, China, 200125
      • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200062
      • Shanghai Children's Hospital
    • Shanghai, Shanghai, China, 201102
      • Affiliated Pediatric Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610073
      • Chengdu Women and Children's Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The guardian and subject are aware of the study procedures, available alternative treatments, and the risks of participating in the study, and voluntarily sign a written ICF to voluntarily participate in the study.
• Age 14-18 years old (excluding 18 years old) at the time of signing the ICF, with bone age greater than 12 years old.
• Height ≥145cm and body mass index (BMI) < 30kg/m2 when signing ICF.
• Diagnosis of idiopathic or congenital hypogonadotropic hypogonadism.
• The presence of bilateral pre-gonadal onset testis during the screening period: testicular volume <4 mL on each side (determined by ultrasound and evaluated by 2 qualified ultrasound specialists authorized by the researchers of the research center).
• The circulating gonadotropin (Gn) level was low (FSH≤1 IU/L and LH≤1 IU/L) during the screening period, and the peak LH value of GnRH excitation test was ≤4 IU/L.
• Serum testosterone T ≤ 1 ng/mL during the screening period.
• The normal range of other pituitary hormones during the screening period (judged by the researcher).
• Lesions detected by MRI on the head within 3 months before or during screening were normal or determined by the investigator to have no impact on the study.
• Consent to the use of reliable contraception (e.g. abstinence, condoms, etc.) by yourself and your sexual partner during the study period and for 3 months after the study drug treatment.

Exclusion Criteria:

There is primary hypogonadism (e.g., Klinefelter syndrome).

• Hypogonadotropic hypogonadism caused by tumor, surgery, trauma, infection, or immune factors in the hypothalamic sella or pituitary gland.
• History of unilateral or bilateral cryptorchidism and the presence of clinically significant testicular lesions (orchitis, testicular tumor, testicular torsion, severe varicocele (grade III), testicular atrophy, obstructive azoospermia, etc.).
• Researchers identified uncontrolled endocrine diseases, including thyroid, adrenal diseases, diabetes, etc.
• History of malignant tumors within 5 years prior to the screening period.
• Patients who have received GnRH, gonadotropin or oral androgen (testosterone, etc.) therapy within 1 month before signing ICF, or who have received testosterone undecanoate intramuscular injection therapy within 1 year before signing ICF.
• History of drug or substance abuse within 1 year prior to signing the ICF, drugs known to impair testicular function or affect the production of sex hormones, or alcohol abuse.
• Abnormal liver and kidney function during screening, i.e. liver function: alanine aminotransferase and/or aspartate aminotransferase higher than 2 times the upper limit of normal (>2×Upper limit of normal); Renal function: Creatinine and/or urea/urea nitrogen are 2 times higher than the upper limit of normal (>2×Upper limit of normal).
• During the screening period, patients with systemic diseases (such as metabolic abnormalities, circulatory, digestive, nervous system, etc.) judged by the researchers are not suitable for participation in this study.
• Current thromboembolic disease or known prior history.
• Hepatitis B surface antigen, hepatitis C antibody, HIV antibody and treponema pallidum antibody positive.●
• People who are allergic to the active ingredients or excipients of FSH and hCG drugs or have a history of related allergies, or have a clear contraindication of drug use.
• Participants who participated in other interventional clinical trials and used experimental drugs within 3 months prior to screening.
• Patients with a history of depression or mental disorders.
• Due to risk considerations, the researchers did not consider it appropriate to participate in other situations in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 30subjects：GenSci094 was administered for 12 weeks，150ug/0.5ml（weight>60kg）or 100ug/0.5ml（weight≤60kg）；GenSci094 with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight>60kg）or 100ug/0.5ml（weight≤60kg）with chorionic gonadotropin for injection.	Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection; IF Weight > 60kg，150ug, H. Administer the drug once every 14 days for 64 weeks；IF Weight >≤60kg，100ug, H. Administer the drug once every 14 days for 64 weeks
Placebo Comparator: Placebo group; 30subjects：GenSci094 Placebo was administered for 12 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight<60kg）；GenSci094 Placebo with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight<60kg）with chorionic gonadotropin for injection.	Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo; 0.5ml, H. Administer the drug once every 14 days for 64 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks	64 weeks after administration

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2024
• Primary Completion (Estimated): November 23, 2024
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Hormones
• Other Study ID Numbers: GenSci094-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No