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

Start Date20 Sep 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

CTR20243077 / RecruitingPhase 3

一项在14至18岁青少年男性特发性低促性腺激素性性腺功能减退症（IHH）中评估重组人促卵泡激素-CTP融合蛋白注射液（rhFSH-CTP）或安慰剂联合注射用绒促性素（hCG）启动或恢复青春期的疗效和安全性的多中心、随机双盲、III期临床研究

[Translation] 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 (rhFSH-CTP) or placebo combined with injectable chorionic gonadotropin (hCG) in initiating or resuming puberty in adolescent males aged 14 to 18 years with idiopathic hypogonadotropic hypogonadism (IHH)

主要目的是在中国14至18岁青少年男性IHH中评估GenSci094联合hCG给药启动或恢复青春期的疗效；次要目的是评估GenSci094联合hCG给药在除睾丸体积外其他青春期启动或恢复方面的疗效，评估GenSci094的药代动力学（PK）特征、安全性、免疫原性。

[Translation]

The primary objective is to evaluate the efficacy of GenSci094 combined with hCG administration in initiating or resuming puberty in Chinese adolescent males aged 14 to 18 years with IHH; the secondary objective is to evaluate the efficacy of GenSci094 combined with hCG administration in other aspects of puberty initiation or resuming except testicular volume, and to evaluate the pharmacokinetic (PK) characteristics, safety, and immunogenicity of GenSci094.

Start Date11 Sep 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

NCT05896293 / RecruitingPhase 2IIT

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.
Funding Source: FDA OOPD

Start Date03 Feb 2023

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

100 Clinical Results associated with Idiopathic Hypogonadotropic Hypogonadism

100 Translational Medicine associated with Idiopathic Hypogonadotropic Hypogonadism

0 Patents (Medical) associated with Idiopathic Hypogonadotropic Hypogonadism

845

Literatures (Medical) associated with Idiopathic Hypogonadotropic Hypogonadism

01 Nov 2024·Free Radical Biology and Medicine

Effects of intermittent exposure to hypobaric hypoxia and cold on skeletal muscle regeneration: Mitochondrial dynamics, protein oxidation and turnover

Article

Author: Sánchez-Nuño, Sergio ; Torrella, Joan Ramon ; Viscor, Ginés ; Carbonell, Teresa ; Bardallo, Raquel G ; Girabent-Farrés, Montserrat ; Santocildes, Garoa ; Rebull, Josep

Muscle injuries and the subsequent regeneration events compromise muscle homeostasis at morphological, functional and molecular levels. Among the molecular alterations, those derived from the mitochondrial function are especially relevant. We analysed the mitochondrial dynamics, the redox balance, the protein oxidation and the main protein repairing mechanisms after 9 days of injury in the rat gastrocnemius muscle. During the recovery rats were exposed to intermittent cold exposure (ICE), intermittent hypobaric hypoxia (IHH), and both simultaneous combined stimuli. Non-injured contralateral legs were also analysed to evaluate the specific effects of the three environmental exposures. Our results showed that ICE enhanced mitochondrial adaptation by improving the electron transport chain efficiency during muscle recovery, decreased the expression of regulatory subunit of proteasome and accumulated oxidized proteins. Exposure to IHH did not show mitochondrial compensation or increased protein turnover mechanisms; however, no accumulation of oxidized proteins was observed. Both ICE and IHH, when applied separately, elicited an increased expression of eNOS, which could have played an important role in accelerating muscle recovery. The combined effect of ICE and IHH led to a complex response that could potentially impede optimal mitochondrial function and enhanced the accumulation of protein oxidation. These findings underscore the nuanced role of environmental stressors in the muscle healing process and their implications for optimizing recovery strategies.

01 Oct 2024·Journal of Neuroendocrinology

Lack of a genetic risk continuum between pubertal timing in the general population and idiopathic hypogonadotropic hypogonadism

Article

Author: Balasubramanian, Ravikumar ; Plummer, Lacey ; Salnikov, Kathryn ; Lippincott, Margaret ; Dewan, Pranav ; Seminara, Stephanie ; Campbell, Mark ; Bryant, Nora ; Stamou, Maria

AbstractPubertal timing is a highly heritable trait in the general population. Recently, a large‐scale exome‐wide association study has implicated rare variants in six genes (KDM4C, MC3R, MKRN3, PDE10A, TACR3, and ZNF483) as genetic determinants of pubertal timing within the general population. Two of the genes (TACR3, MKRN3) are already implicated in extreme disorders of pubertal timing. This observation suggests that there may be a pervasive “genetic risk continuum” wherein genes that govern pubertal timing in the general population, by extension, may also be causal for rare Mendelian disorders of pubertal timing. Hence, we hypothesized that the four novel genes linked to pubertal timing in the population will also contribute to idiopathic hypogonadotropic hypogonadism (IHH), a genetic disorder characterized by absent puberty. Exome sequencing data from 1322 unrelated IHH probands were reviewed for rare sequence variants (RSVs) (minor allele frequency bins: <1%; <0.1%; <0.01%) in the six genes linked to puberty in the general population. A gene‐based rare variant association testing (RVAT) was performed between the IHH cohort and a reference public genomic sequences repository—the Genome Aggregation Database (gnomAD). As expected, RVAT analysis showed that RSVs in TACR3, a known IHH gene, were significantly enriched in the IHH cohort compared to gnomAD cohort across all three MAF bins. However, RVAT analysis of the remaining five genes failed to show any RSV enrichment in the IHH cohort across all MAF bins. Our findings argue strongly against a pervasive genetic risk continuum between pubertal timing in the general population and extreme pubertal phenotypes. The biologic basis of such distinct genetic architectures' merits further evaluation.

01 Aug 2024·Acta Radiologica

Role of neuroimaging markers on predicting of idiopathic intracranial hypertension

Article

Author: Akıncı, Okan ; Ulutaş, Can ; Hasırcı Bayır, Buse Rahime ; Yıldız, Selçuk ; Balık, Ayşe Özlem

Background The goals of neuroimaging in idiopathic intracranial hypertension (IIH) are the exclusion of mimickers and effective management of disease. In recent studies, several imaging markers have been identified as potential predictors of IIH. Purpose To investigate the predictive roles of novel radiological markers as the Meckel's cave area, alongside classical radiologic markers in identifying IIH such as the empty sella. Material and Methods The patients were classified according to cerebrospinal fluid (CSF) opening pressure as the IIH group and control group. The observational, case-control study included 22 patients with IIH and 22 controls. Groups were compared for presence of empty sella, Meckel's cave area, fat area of posterior neck, fat thickness of scalp, presence of transverse sinus stenosis, and ophthalmic markers, such as increase of optic nerve (ON) sheath diameter. Results In the IHH group, higher occurrences of increased ON sheath diameter, ON tortuosity, flattening of the scleral surface, and transverse sinus stenosis were observed ( P < 0.001, P < 0.001, P = 0.046, and P = 0.021, respectively). Meckel's cave area and fat area of posterior neck were similar in both groups ( P = 0.444 and P = 0.794). Conclusion Ophthalmic markers and transverse sinus stenosis could be utilized as radiologic features supporting early and precise diagnosis of IIH. However, enlargement of Meckel's cave area and measurements of fatty area of posterior neck are not helpful for diagnosis of IIH.

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