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

NCT06561594 | Not Yet Recruiting Phase 3

• 1 other identifier: GenSci094-303
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

recombinant human follicle-stimulating hormone-CTP Fusion protein injection DRUG

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

Experimental group

recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo DRUG

0.5ml, H. Administer the drug once every 14 days for 64 weeks

Placebo group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (17)

Anhui Children's Hospital

Hefei, Anhui, 230022, China

Location

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Peking Union Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Women and Children's Medical Center Affiliated to Guangzhou Medical University

Guangzhou, Guangdong, 510623, China

Location

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518026, China

Location

Henan Children's Hospital Zhengzhou Children's Hospital

Zhengzhou, Henan, 450018, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Nanjing Children's Hospital

Nanjing, Jiangsu, 210093, China

Location

Jiangxi Children's Hospital

Nanchang, Jiangxi, 330200, China

Location

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004, China

Location

Affiliated Hospital of Jining Medical College

Jining, Shangdong, 272100, China

Location

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, 200062, China

Location

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200125, China

Location

Affiliated Pediatric Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Chengdu Women and Children's Central Hospital

Chengdu, Sichuan, 610073, China

Location

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Central Study Contacts

lingling Li

CONTACT

+86-18826108784; lilingling01@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: September 20, 2024
• Primary Completion: November 23, 2024
• Study Completion (Estimated): December 23, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CN (17)