庚酸炔诺酮(Norethisterone Enanthate) - 药物靶点：PR_在研适应症：不孕，子宫出血_专利_临床

概要

基本信息

药物类型

小分子化药

别名

NORETHISTERONE ENANTHAS、Norethisterone oenanthate

+ [4]

靶点

PR

作用机制

PR激动剂(孕激素受体激动剂)

治疗领域

泌尿生殖系统疾病

在研适应症

不孕子宫出血

非在研适应症-

原研机构

浙江仙琚制药股份有限公司

在研机构

浙江仙琚制药股份有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C27H38O3

InChIKeyAPTGJECXMIKIET-WOSSHHRXSA-N

CAS号3836-23-5

关联

10

项与庚酸炔诺酮相关的临床试验

NCT05362019 / Unknown statusN/AIIT

Effects of One-to-one Service on the Continuation and Satisfaction of Combined Injectable Contraceptive Use.

This study aims to explore the impact of a mobile based one-to-one service model on improving the continuation and satisfaction of combined injectable contraceptive use, and improve the utilization and acceptability of efficient and long-term contraceptive methods.

开始日期2022-05-01

申办/合作机构-

ChiCTR2100055053 / Recruiting临床4期IIT

Prospective, multi-center clinical study on the effect of immediate injection of compound norethisterone enanthate on the menstrual pattern and improvement of dysmenorrhea after abortion

开始日期2022-01-03

申办/合作机构

广州市妇女儿童医疗中心

CTRI/2019/06/019490 / Completed临床3期

A Phase III, Multi-center, Prospective, Randomized, Double Blind, Single Dummy, Active Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Norethisterone CR Tablets 15 mg versus Norethisterone Tablets 5 mg to Arrest Bleeding in Women with Heavy Menstrual Bleeding (HMB) / Abnormal Uterine bleeding (AUB) due to Hormonal Imbalance.

开始日期2019-06-03

申办/合作机构

Synokem Pharmaceuticals Ltd.

100 项与庚酸炔诺酮相关的临床结果

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100 项与庚酸炔诺酮相关的转化医学

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100 项与庚酸炔诺酮相关的专利（医药）

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302

项与庚酸炔诺酮相关的文献（医药）

2023-11-01·American Journal of Reproductive Immunology

Contraceptive effects on the cervicovaginal microbiome: Recent evidence including randomized trials

Review

作者: Heffron, Renee ; Happel, Anna‐Ursula ; Jaspan, Heather B. ; Balle, Christina

AbstractBackgroundUntil recently, most data regarding the effects of non‐barrier contraceptives on the mucosal microbiome have derived from observational studies, which are potentially biased due to behavioral confounders that may mask their true biological effects.Method of StudyThis narrative review summarises recent evidence of the effect of contraceptives on the cervicovaginal microbiome, emphasising data obtained through randomized trials.ResultsGood quality data describe that initiation of long‐acting progestin‐only contraceptives, including levonorgestrel (LNG)‐implant and the injectables depot‐medroxyprogesterone acetate (DMPA‐IM) and norethisterone enanthate (NET‐EN) do not alter the mucosal microbial environment. Likewise, no strong evidence exists that the use of oral contraceptive pills (OCPs) is associated with alterations of the vaginal microbiome or increased risk of bacterial sexually transmitted infections (STIs). Limited data on the effect of intravaginal rings (IVRs) on the mucosal environment exist and show conflicting effects on the vaginal microbiota. Copper intrauterine device (Cu‐IUD) initiation has been associated with bacterial vaginosis (BV) acquisition, including in a randomized trial. LNG‐IUDs may have similar affects but need to be evaluated further.ConclusionDifferent synthetic hormones have divergent effects on the microbiome and therefore novel hormonal methods need to be rigorously evaluated. Furthermore, the addition of antiretrovirals into multipurpose technologies may alter the effects of the hormonal component. There is thus a critical need to improve our understanding of the biological effects of contraceptive hormones and delivery methods with different pharmacokinetic and chemical properties on the mucosal microbiome in rigorous trials, to inform the development of novel contraceptives and improve individual family planning guidance.

2021-08-01·American Journal of Reproductive Immunology3区 · 医学

Genital and systemic immune effects of the injectable, contraceptive norethisterone enanthate (NET‐EN), in South African women

3区 · 医学

Article

作者: Mchunu, Nobuhle ; Molatlhegi, Refilwe P. ; Zondi, Mthobisi M. ; Ngcapu, Sinaye ; Govender, Katya ; Samsunder, Natasha ; Leslie, Alasdair ; Ngcobo, Samkelisiwe ; Liebenberg, Lenine J. P. ; Adamson, John H. ; Sivro, Aida ; Mabhula, Amanda ; Karim, Quarraisha Abdool ; Passmore, Jo‐Ann S. ; McKinnon, Lyle R. ; Karim, Salim S. Abdool

AbstractProblemInjectable hormonal contraceptives (IHC) have been associated with altered mucosal and systemic milieu which might increase HIV risk, but most studies have focused on DMPA and not NET‐EN, despite the growing popularity and lower HIV risk associated with the latter in observational studies.Method of studyWe used high‐performance liquid chromatography in combination with tandem triple quadrupole mass spectrometry (HPLC‐LC‐MS/MS) to measure steroid hormones in plasma samples of CAPRISA004 study participants. Concentrations of 48 cytokines were measured in the cervicovaginal lavage (CVL) and plasma, and their expression was compared between participants with detectable NET‐EN (n = 201) versus non‐detectable IHC (n = 90). Each log10 cytokine concentration was tested as an outcome in linear‐mixed models, with NET‐EN detection as the main explanatory variable. Multivariable models were adjusted for potential confounders.ResultsIn bivariate analysis, detectable NET‐EN was associated with reduced cervicovaginal M‐CSF (P = 0.008), GM‐CSF (P = 0.025) and G‐CSF (P = 0.039), and elevated levels MIF (P = 0.008), IL‐18 (P = 0.011), RANTES (P = 0.005) and IL‐1Rα (P < 0.001). Lower G‐CSF (P = 0.011) and elevated IL‐1Rα (P = 0.008) remained significant in adjusted models. Multivariable analyses of plasma samples obtained from NET‐EN‐detectable women showed a significant increase in IP‐10 (P = 0.026) and reductions in TNF‐β (P = 0.037), RANTES (P = 0.009), and M‐CSF (P < 0.001). While similar growth factor reduction in CVL was noted for both DMPA and NET‐EN, similar trends were not observed for endogenous progesterone.ConclusionsDetectable NET‐EN was associated with reduced growth factors in the plasma and genital tract; particularly G‐CSF and M‐CSF. Our results suggest that while NET‐EN is not inflammatory, it may have important immunological effects.

2021-07-01·American Journal of Reproductive Immunology3区 · 医学

Effect of injectable progestin‐only contraceptives, depot medroxyprogesterone acetate and norethisterone enanthate, on cytokine production during T‐cell activation

3区 · 医学

Article

作者: Mhlanga, Felix ; Mbizvo, Mike ; Stoner, Kevin A. ; Meyn, Leslie A. ; Chirenje, Zvavahera M. ; Maramba, Aaron ; Achilles, Sharon L. ; Hillier, Sharon L. ; Matubu, Allen T.

AbstractProblemThere is paucity of human data about the effects of depot medroxyprogesterone (DMPA) and norethisterone enanthate (Net‐En) use on systemic immune function, which may have implications for reproductive tract infection susceptibility and transmissibility. We sought to evaluate the impact of injectable contraceptive use on T‐cell responsiveness using T cells exposed in vivo and tested ex vivo.MethodsPeripheral blood mononuclear cells were obtained from healthy, HIV‐negative women after 30, 90 and 180 days of DMPA, norethisterone enanthate (Net‐En) or copper intrauterine device (Cu‐IUD) contraceptive use. Cells were stimulated ex vivo with phorbol myristate acetate and ionomycin, stained and analysed using flow cytometry. Mixed‐effects linear models were used to evaluate change in proportions of T cells producing IFN‐γ, TNF‐α, IL‐4 and IL‐13.ResultsCompared with baseline, decreased proportions of IFN‐γ–producing CD4+ and CD8+ T cells (p = .003, p = .006, respectively) and TNF‐α–producing CD4+ and CD8+ T cells (p = .039, p = .034, respectively) were observed after 180 days of DMPA use. Decreased IL‐4–producing CD4+ and CD8+ T cells (p = .045 and p = .024, respectively) were noted after 180 days of Net‐En use. Decreased IL‐4–producing CD4+ T cells were observed after 30 days (p = .035) and not after 180 days of DMPA use (p = .49). There were no changes in proportion of T cells producing IL‐13 in DMPA users, nor any changes in IFN‐γ, TNF‐α and IL‐13 in Net‐En and Cu‐IUD users.ConclusionIn vivo exposure of CD4+ and CD8+ T cells to typical pharmacologic concentrations of DMPA does not cause broad suppression to stimuli; however, depletion of specific cytokine‐producing T cells may occur after prolonged DMPA use.

100 项与庚酸炔诺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	庚酸炔诺酮	G03AC01 G03DC02	DB14678

研发状态

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适应症	国家/地区	公司	日期
不孕	中国	浙江仙琚制药股份有限公司	-
子宫出血	中国	浙江仙琚制药股份有限公司	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


MDP 301 (IAS2018)	N/A	单纯疱疹	621	Depo-medroxyprogesterone acetate (DMPA)	積衊鹽廠壓衊範膚選衊(願顧壓鑰襯鬱艱鹹積簾) = 構簾觸壓廠憲窪鬱顧鏇簾築鬱鏇獵築顧鑰糧齋 (艱願壓蓋窪遞範糧遞鏇 )	-	2018-01-01
				Norethisterone enanthate (Net-EN)	積衊鹽廠壓衊範膚選衊(願顧壓鑰襯鬱艱鹹積簾) = 築觸積蓋壓淵鹹夢衊築簾築鬱鏇獵築顧鑰糧齋 (艱願壓蓋窪遞範糧遞鏇 )
IAS2016	N/A	HIV感染	232	Depot medroxyprogesterone acetate (DMPA)	鑰襯淵膚鏇艱醖繭壓襯(齋鏇鏇廠積繭選壓糧夢): Unadjusted HR = 0.67 (95% CI, 0.24 ~ 1.85); Adjusted HR = 0.71 (95% CI, 0.26 ~ 1.97) 更多	-	2016-01-01
				Norethisterone enanthate (NET-EN)