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

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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1,480

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

2025-01-01·Psychoneuroendocrinology

Growth Differentiation Factor 15 during pregnancy and postpartum as captured in blood, cerebrospinal fluid and placenta: A cohort study on associations with maternal mental health

Article

作者: Renault, Kristina M ; Bruzzone, Silvia EP ; Frokjaer, Vibe G ; Frokjaer, Vibe G. ; Clemmensen, Christoffer ; Borgsted, Camilla ; Hegaard, Hanne K. ; Bruzzone, Silvia Ep ; Renault, Kristina M. ; Høgh, Stinne ; Hegaard, Hanne K ; Ekelund, Kim ; Klein, Anders B ; Klein, Anders B.

INTRODUCTIONGrowth Differentiation Factor 15 (GDF15) increases substantially during pregnancy and is primarily produced by the placenta. Elevated levels of GDF15 have been associated with mental health problems in non-perinatal populations, higher corticosterone levels, and decreased estrogen receptor activity. However, the role of GDF15 in mental health during the perinatal transition remains unknown. This longitudinal study is the first to evaluate pregnancy levels of GDF15 in cerebrospinal fluid (cGDF15), plasma (pGDF15) and placenta GDF15 mRNA, along with mapping plasma GDF15 (pGDF15) level changes from late pregnancy to early postpartum. Moreover, we aimed to evaluate the association between pregnancy cGDF15 levels and cortisol early postpartum, evaluate the association between pregnancy cGDF15 levels and mental health in pregnancy and postpartum, and evaluate the association between pGDF15 and estrogens and high-sensitivity C-reactive protein (CRP).METHODSWe included data from 95 women scheduled for a planned cesarean section and obtained cerebrospinal fluid (CSF) and plasma levels of GDF15. We quantified GDF15 mRNA levels in placenta biopsies. Estrogens, high-sensitivity CRP, and mental health measures were further collected on the day or one day before the cesarean section. At five weeks postpartum, mental health measures and saliva samples for cortisol analyses were collected. Correlation analyses for GDF15 in CSF, plasma, and placenta mRNA were performed, along with association analyses for pregnancy cGDF15, Cortisol Awakening Response, and mental health outcomes.RESULTSWe demonstrated a strong correlation between cGDF15 and pGDF15 (r=0.52; p<0.001) and found that both cGDF15 and pGDF15 correlated with placenta GDF15 mRNA*placental weight (r=0.62, p<0.001 and r=0.44, p=0.008, respectively). During late pregnancy, both estradiol (E2) and estriol (E3) were significantly associated with pGDF15 levels (E2: p=0.002; E3: p(corrected)<0.001). Finally, we found that cGDF15 levels were not associated with self-reported mental well-being or the Cortisol Awakening Response or absolute cortisol at awakening postpartum.CONCLUSIONThis novel study points to the unique hormonal landscape during the perinatal transition and the specific role of GDF15 in pregnancy, which appears uncoupled with perinatal mental health and cortisol outcomes. Our data also strongly imply that the overall amount of circulating GDF15 in late pregnancy is closely related to placenta size.

2024-12-31·Stress

Developmental and adult stress: effects of steroids and neurosteroids

Review

作者: Gould, Elizabeth ; Gore, Isha R

In humans, exposure to early life adversity has profound implications for susceptibility to developing neuropsychiatric disorders later in life. Studies in rodents have shown that stress experienced during early postnatal life can have lasting effects on brain development. Glucocorticoids and sex steroids are produced in endocrine glands and the brain from cholesterol; these molecules bind to nuclear and membrane-associated steroid receptors. Unlike other steroids that can also be made in the brain, neurosteroids bind specifically to neurotransmitter receptors, not steroid receptors. The relationships among steroids, neurosteroids, and stress are multifaceted and not yet fully understood. However, studies demonstrating altered levels of progestogens, androgens, estrogens, glucocorticoids, and their neuroactive metabolites in both developmental and adult stress paradigms strongly suggest that these molecules may be important players in stress effects on brain circuits and behavior. In this review, we discuss the influence of developmental and adult stress on various components of the brain, including neurons, glia, and perineuronal nets, with a focus on sex steroids and neurosteroids. Gaining an enhanced understanding of how early adversity impacts the intricate systems of brain steroid and neurosteroid regulation could prove instrumental in identifying novel therapeutic targets for stress-related conditions.

2024-12-01·Clinical Nutrition ESPEN

Evaluating changes in body composition, bone mass, and metabolic profile in an animal model undergoing transfeminine hormone therapy and physical exercise

Article

作者: Dias-da-Silva, Magnus R ; Almeida, Isadora Gonçalves ; Beserra, Nathália ; Rodrigues, Felipe Behrends ; Cordeiro, Emily Rocha ; da Silva, Magnus R. Dias ; Lichtenecker, Débora C K ; Ferreira, João Guimarães ; Gois, Ísis ; Silveira, Isabela Borges da ; Lichtenecker, Débora C.K. ; Gomes, Guiomar Nascimento ; Castro, Charlles Heldan de Moura

BACKGROUND & AIMSGender-affirming hormone therapy (GAHT) is essential for transgender individuals seeking body modifications. For transfeminine people assigned male at birth, GAHT typically involves a combination of antiandrogens and estrogens. Despite its importance, the scientific literature presents inconsistencies regarding the effects of these hormones on nutritional status, body composition, and biochemical markers. This study aims to evaluate the impact of estradiol enanthate and dihydroxyprogesterone acetophenide (E2EN/DHPA) hormonal treatment, in conjunction with resistive physical exercise, on body composition and metabolic profiles.METHODSTwenty-eight male rats were divided into three groups: MO (control group, n = 8), receiving sesame oil vehicle; MH (n = 11), receiving E2EN/DHPA; and MEH (n = 9), receiving E2EN/DHPA along with physical exercise. The hormonal treatment was administered every ten days for two months, while the exercise regimen involved stair climbing with progressively increasing weights, performed five times weekly for seven weeks. Evaluated parameters included body mass index (BMI), body composition (fat and lean mass), bone mineral density (BMD), and lipid profile (triglycerides, HDL-C, LDL-C).RESULTSThe rats that received E2EN/DHPA showed significant changes in body composition and BMI, regardless of exercise. The MH group had increased body fat, while both the MH and MEH groups had decreased bone area and mineral content. However, BMD remained the same across all groups. Elevated triglyceride levels were observed, and the MEH group also had reduced LDL-C levels. HDL-C levels did not show significant variation.CONCLUSIONThe study's findings show similarities to changes seen in transfeminine individuals undergoing GAHT with estrogen and antiandrogens. These changes include decreased muscle mass, increased body fat, preserved bone mineral density, and elevated triglycerides. The study also found that resistance exercise positively impacted lipid profiles, particularly in reducing LDL-C. These results highlight the need for further research and comparative trials on hormone therapy regimens.

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1期	美国	Aspen Pharma USA Inc.	2007-04-23

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临床结果

适应症

分期

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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)	鬱壓鹹鏇製遞範淵襯糧(鑰憲網遞製鏇襯醖醖願) = 簾醖醖遞築遞窪繭淵壓醖鬱願願積簾繭製艱積 (憲衊艱積範鹹膚獵鹹襯, 遞鬱糧選壓選遞鬱願構 ~ 齋鹽願襯齋醖襯觸觸醖) 更多	-	2010-03-17
				SCE-B (0.625 mg SCE-B Daily)	鬱壓鹹鏇製遞範淵襯糧(鑰憲網遞製鏇襯醖醖願) = 鏇衊衊獵襯繭鹹範膚壓醖鬱願願積簾繭製艱積 (憲衊艱積範鹹膚獵鹹襯, 糧願壓鏇繭觸獵網蓋繭 ~ 淵願遞齋選襯壓構夢積) 更多