合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.)(Estrogens, Conjugated Synthetic B(Teva Pharmaceutical Industries Ltd.))

概要

基本信息

药物类型

小分子化药

别名

Conjugated estrogens、Enjuvia、Estrogens, Conjugated Synthetic B

+ [4]

靶点

ER

作用机制

ERs激动剂(雌激素受体家族激动剂)

治疗领域

心血管疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

阴道粘膜干燥血管舒缩症外阴和阴道萎缩

原研机构

Teva Pharmaceutical Industries Ltd.

在研机构-

非在研机构

Teva Women's Health, Inc.Teva Branded Pharmaceutical Products R&D, Inc.Aspen Pharma USA Inc.

最高研发阶段撤市

首次获批日期

美国 (2004-05-10),

血管舒缩症

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C18H20NaO5S

InChIKeyRMFRALSRVMTLBI-QWAPEVOJSA-N

CAS号16680-47-0

关联

3

项与合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.) 相关的临床试验

CTRI/2024/08/072592

/ RecruitingN/A

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-Arm, Parallel-Study to Evaluate the Bioequivalence using Clinical Endpoint of generic conjugated estrogens vaginal cream, 0.625 mg/g (Novast Laboratories, Ltd., China) to Premarin® (conjugated estrogens) vaginal cream, 0.625mg/g (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.), in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy. - nil

开始日期2024-08-30

申办/合作机构

南通联亚药业股份有限公司

NCT00592839

/ Completed临床4期

A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women

This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.

开始日期2007-12-01

申办/合作机构

Teva Branded Pharmaceutical Products R&D, Inc.

NCT00196378

/ Completed临床3期

A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

开始日期2004-11-01

申办/合作机构

Teva Branded Pharmaceutical Products R&D, Inc.

100 项与合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.) 相关的临床结果

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100 项与合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.) 相关的转化医学

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100 项与合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.) 相关的专利（医药）

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1,572

项与合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.) 相关的文献（医药）

2025-04-15·Rapid Communications in Mass Spectrometry

Covalent Organic Framework Nanofilm‐Assisted Laser Desorption Ionization Mass Spectrometry for Rapid Screening of Parabens in Personal Care Products

Article

作者: Zheng, Wenjun ; Cai, Zongwei ; Lin, Zian ; Yan, Jingjing ; Jin, Yingxue

ABSTRACTRationalPeople are widely exposed to parabens in their daily life, but parabens are endocrine disrupting chemicals that pose a threat to human health. Therefore, establishing a rapid screening method to enhance monitoring of parabens is necessary. Herein, a covalent organic framework (COF) nanofilm‐assisted laser desorption ionization mass spectrometry (LDI‐MS) method was established to screen parabens in personal care products (PCPs).MethodsTAPB‐TFPB‐COF nanofilm was synthesized on indium tin oxide (ITO) glass and used as LDI‐MS substrates. To observe the practicability of TAPB‐TFPB‐COF nanofilm‐assisted LDI‐MS, the results of this method for analyzing small molecules such as parabens, estrogens, and bisphenols were compared with those of the conventional organic matrix 9‐aminoacridine (9‐AA), and the reproducibility and detection limit were further verified. Finally, the method was applied to screen parabens in PCPs.ResultsTAPB‐TFPB‐COF nanofilm‐assisted LDI‐MS analyzed small molecules such as parabens, estrogens, and bisphenols with higher mass spectral signals and cleaner mass spectral backgrounds compared with 9‐AA. Meanwhile, the method analyzed methylparaben (MeP) with high reproducibility (RSD = 6.96%) and low detection limit (1.64 μM) and performed well for rapid screening of parabens in PCPs.ConclusionTAPB‐TFPB‐COF nanofilm‐assisted LDI‐MS for analyzing small molecules such as parabens, estrogens, and amino acids offered the advantages of rapid analysis, a clean background, and good reproducibility. The method was successfully applied to detecting parabens in PCPs, demonstrating the practical utility of LDI‐MS based on TAPB‐TFPB‐COF nanofilm for analyzing parabens in complex samples.

2025-02-01·Contraception

Lower reporting of venous thromboembolisms events with natural estrogen-based combined oral contraceptives compared to ethinylestradiol-containing pills: A disproportionality analysis of the Eudravigilance database

Article

作者: Didembourg, Marie ; Douxfils, Jonathan ; Raskin, Lucie ; Tchimchoua, Babel Tsague ; Locquet, Médéa ; Beaudart, Charlotte ; Dogné, Jean-Michel

OBJECTIVESPharmacovigilance data analysis can accelerate the identification of drug-related safety signals or reassure on the safety profile. This study evaluates the venous thromboembolism (VTE) risk of newer combined oral contraceptive (COC) formulations with natural estrogens, such as estradiol (E2) and estetrol (E4), using data from the EudraVigilance database.STUDY DESIGNWe conducted a disproportionality reporting rate analysis of VTE events associated with various COC formulations by extracting individual case reports from EudraVigilance database up to July 28, 2024. The study compared the proportionality reporting rate between natural estrogen-based COCs (E2 and E4) and conventional synthetic estrogen-based COCs (ethinylestradiol [EE]), with a comparison to EE-levonorgestrel.RESULTSThe analysis revealed that COCs containing natural estrogens exhibited significantly lower proportionality reporting rates for thrombotic events compared to EE-based COCs. Specifically, E4-drospirenone (E4-DRSP) showed the lowest proportionality reporting rate (0.12), similar to progestin-only pills. EE-DRSP had the highest proportionality reporting rate (2.25), suggesting an increased thrombotic risk.CONCLUSIONSThe study supports the safer thrombotic profile of natural estrogen-based COCs, particularly E2 and E4 formulations, over synthetic estrogen-based COCs containing EE. These findings support the hypothesis that E2- and E4-based pills are safer than EE-based pills, aligning with a shift toward safer contraceptive options in clinical practice.IMPLICATIONSNatural estrogens such as E2 and E4 may emerge as safer alternatives to synthetic estrogens like EE, particularly when combined with progestins like DRSP. This multilevel evidence underscores the importance of evidence-based prescribing practices to enhance patient safety and minimize thrombotic risks associated with COC use.

2025-02-01·Food and Chemical Toxicology

Predicting in vivo concentrations of dietary hop phytoestrogens by physiologically based kinetic modeling

Article

作者: Punt, Ans ; Beekmann, Karsten ; Stevanoska, Maja ; Aichinger, Georg ; Sturla, Shana J

Hop extracts containing prenylated polyphenols such as 8-prenylnaringenin (8-PN) and its precursor isoxanthohumol (iXN) are popular among women seeking natural alternatives to hormone therapy for postmenopausal symptoms. Due to structural similarities with estrogens, these compounds act as estrogen receptor agonists. Especially 8-PN, described as the most potent phytoestrogen known to date, poses a potential risk for endocrine disruption. Therefore, its use as a hormone replacement raises concerns for human health. However, a significant challenge in assessing the potential endocrine-disruptive effects of hop polyphenols is the lack of data on their toxicokinetics. Particularly, information on in vivo concentrations in target tissues is lacking. To address this gap, we developed a physiologically based kinetic (PBK) model tailored to female physiology. The model was used to predict the levels of hop polyphenols in human blood and target tissues under realistic exposure scenarios. The predictions suggest that iXN and 8-PN concentrations in target tissues reach the low nanomolar range after dietary supplementation. This study enhances our understanding of internal concentrations of iXN and 8-PN after dietary consumption and is of direct applicability for respective risk assessment.

100 项与合成结合型雌激素B(Teva Pharmaceutical Industries Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03CA	DB09318

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
外阴和阴道萎缩	临床前	美国	Aspen Pharma USA Inc.	2007-04-23

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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


NCT00592839 (CTgov)	临床4期	血管舒缩症	157	SCE-B (0.3 mg SCE-B Daily)	壓膚範憲簾獵齋遞襯獵(膚壓觸範糧夢簾積廠鹹) = 壓選鏇顧蓋積鑰簾築餘醖餘獵鹽廠鑰艱觸鑰廠 (製壓簾齋遞艱獵衊廠淵, 夢鬱鹹鏇範窪願餘網鏇 ~ 選膚顧夢襯齋築醖窪遞) 更多	-	2010-03-17
				SCE-B (0.625 mg SCE-B Daily)	壓膚範憲簾獵齋遞襯獵(膚壓觸範糧夢簾積廠鹹) = 蓋憲艱淵鏇淵壓衊鑰範醖餘獵鹽廠鑰艱觸鑰廠 (製壓簾齋遞艱獵衊廠淵, 淵糧襯窪繭製鑰壓鑰廠 ~ 築糧積齋築餘艱鹹顧範) 更多