Idiopathic Hypogonadotropic HypogonadismPhase 3NCT06561594
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
A Phase 3 study testing recombinant human follicle-stimulating hormone-CTP Fusion protein injection in people with Idiopathic Hypogonadotropic Hypogonadism, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 17 sites in China.
Trial summary
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection Read more about this study
- Who is it for?
- Ages 14 to 17 years, men only
- Conditions the study is for
- Idiopathic Hypogonadotropic Hypogonadism
- What is being tested?
- recombinant human follicle-stimulating hormone-CTP Fusion protein injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 17 sitesChina
- Study dates
- 20 Sep 2024to 23 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
xueyan Wu, Doctor of Medicine, 010-69154116, wsheyan@vip.sina.com
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, 610073
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Women and Children's Medical Center Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510623
Anhui Children's Hospital
Hefei, Anhui, 230022
Affiliated Hospital of Jining Medical College
Jining, Shangdong, 272100
Jiangxi Children's Hospital
Nanchang, Jiangxi, 330200
Nanjing Children's Hospital
Nanjing, Jiangsu, 210093
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, 200062
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200125
Affiliated Pediatric Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110004
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518026
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, 450018
About this study
Official title: 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
Read the 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.
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Being tested
- recombinant human follicle-stimulating hormone-CTP Fusion protein injection, recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo
- Medical subject headings
- Idiopathic Hypogonadotropic Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human follicle-stimulating hormone-CTP Fusion protein injectionDrug
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
recombinant human follicle-stimulating hormone-CTP Fusion protein injection PlaceboDrug
0.5ml, H. Administer the drug once every 14 days for 64 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks
Measured: 64 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Sep 2024 (estimated)
- Primary completion23 Nov 2024 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561594
- Sponsor's protocol ID
- GenSci094-303
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No