地诺孕素/戊酸雌二醇(Dienogest/Estradiol Valerate) - 药物靶点：ER x PR_在研适应症：月经过多，避孕，雌激素缺乏症状_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ESTRADIOL VALERATE/ESTRADIOL VALERATE/DIENOGEST、Climodien、Natazia

靶点

ER x PR

作用机制

ERs激动剂(雌激素受体家族激动剂)、PR激动剂(孕激素受体激动剂)

治疗领域

内分泌与代谢疾病泌尿生殖系统疾病其他疾病+ [1]

在研适应症

非在研适应症

原研机构

在研机构

Bayer HealthCare Pharmaceuticals, Inc.Bayer BV

+ [1]

非在研机构

Bayer AGSchering GmbH & Co. Produktions KG

拜耳医药保健有限公司

+ [1]

最高研发阶段批准上市

首次获批日期

荷兰 (2001-05-08),

雌激素缺乏症状

最高研发阶段(中国)无进展

特殊审评-

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结构/序列

分子式C20H25NO2

InChIKeyAZFLJNIPTRTECV-FUMNGEBKSA-N

CAS号65928-58-7

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关联

26

项与地诺孕素/戊酸雌二醇相关的临床试验

TCTR20240908003

/ Not yet recruiting临床4期IIT

A comparison of menstrual volume and other benefits between Estradiol valerate/dienogest and Ethinyl estradiol/desogestrel: A randomized controlled trial

开始日期2024-09-01

申办/合作机构

Srinakharinwirot University

NCT06396208

/ RecruitingN/AIIT

"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition: A Single-blind, Randomized Controlled, Non-inferiority Trial

The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are:
Does Estradiol valerate/Dienogest inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle? What are the impacts of Estradiol valerate/Dienogest on ovarian activities when starting on Day 7-9 of menstrual cycle? How does the cervical mucus change when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? What are the adverse effects when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? Researchers will compare Estradiol valerate/Dienogest to Ethinyl estradiol/Gestodene to see if Estradiol valerate/Dienogest inhibit ovulation in quick-starting method.

开始日期2024-05-01

申办/合作机构

University of Chulalongkorn

NCT05332106

/ Completed临床1期

Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product

This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg.
The study will be performed at a single site with 10 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.

开始日期2022-03-12

申办/合作机构

Laboratorios Andrómaco SA

100 项与地诺孕素/戊酸雌二醇相关的临床结果

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100 项与地诺孕素/戊酸雌二醇相关的转化医学

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100 项与地诺孕素/戊酸雌二醇相关的专利（医药）

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14

项与地诺孕素/戊酸雌二醇相关的文献（医药）

2024-06-01·Journal of Assisted Reproduction and Genetics

Impact of dydrogesterone use in cycles with low progesterone levels on the day of frozen embryo transfer

Article

作者: Ferreira, Pedro ; Natário, Isabel ; Santos-Ribeiro, Samuel ; Metello, Jose ; Tomás, Claudia

PURPOSEThis study aims to evaluate whether the clinical outcomes of cycles with frozen embryo transfer (FET) in hormonal replacement treatment supplemented with dydrogesterone (DYD) following detection of low circulating levels of progesterone (P4) were comparable to the results of cycles with otherwise normal serum P4 values.METHODSExtended analyses of a retrospective cohort that included FET cycles performed between July 2019 and March 2022 after a cycle of artificial endometrial preparation using valerate-estradiol and micronized vaginal P4 (400 mg twice daily). Whenever the serum P4 value was considered low on the morning of the planned transfer, 10 mg of DYD three times a day was added as a supplement. Only single-embryo transfers of a blastocyst were considered. The primary endpoint was live birth rate.RESULTSFive-hundred thirty-five FET cycles were analyzed, of which 136 (25.4%) underwent treatment with DYD. There were 337 pregnancies (63%), 207 live births (38.6%), and 130 miscarriages (38.5%). The P4 values could be modeled by a gamma distribution, with a mean of 14.5 ng/ml and a standard deviation of 1.95 ng/ml. The variables female age on the day of FET, ethnicity, and weight were associated with a variation in the serum P4 values. There were no differences in the results between cycles with or without the indication for DYD supplementation.CONCLUSIONSLive birth rate did not vary significantly in females with low and normal serum P4 levels on the day of FET when DYD was used as rescue therapy.

2018-03-01·Journal of Assisted Reproduction and Genetics3区 · 医学

Estrogen treatment in infertile women with premature ovarian insufficiency in transitional phase: a retrospective analysis

3区 · 医学

Article

作者: Sergiampietri, Claudia ; Simi, Giovanna ; Basile, Stefano ; Giannarelli, Diana ; Artini, Paolo Giovanni ; Obino, Maria Elena Rosa ; Cela, Vito ; Pinelli, Sara

PURPOSEDuring the transitional phase of premature ovarian insufficiency (POI), sporadic resumption of ovulation is possible because of fluctuation of hormonal levels but the chance of spontaneous pregnancy is low, and the main perspective of childbearing in these women is egg donation or adoption. The purpose of the study was to verify whether treatment with estrogens in POI patients in transitional phase could reduce FSH levels and to evaluate if this pre-treatment could improve reproductive outcomes of in vitro fertilization (IVF).METHODSStudy patients (26) were administered with valerate estradiol 2 mg daily adding dihydrogesterone 10 mg daily during luteal phase for 3 months before IVF. Control group (26 patients) did not receive any pre-treatment. Ovarian stimulation was conducted in both groups with the same short GnRH-antagonist protocol. Clinical and laboratory data of patients were retrospectively analyzed.RESULTSIn the study group, 4/26 POI patients became spontaneously pregnant during pre-treatment. In the remaining patients, the mean level of FSH after the pre-treatment was significantly reduced compared with baseline. Levels of circulating estradiol on the day of hCG administration were significantly higher in the study group. The total number of MII oocytes retrieved and fertilized oocytes was significantly higher in the study group, as well as the number of embryos transferred for pickup and clinical pregnancy rate.CONCLUSIONSTreatment with estrogens in infertile POI patients in transitional phase reduces circulating FSH levels, hence causing potential spontaneous conception. Moreover, in these patients, estrogen pre-treatment seems to improve IVF outcomes in a GnRH-antagonist short protocol compared to no pre-treatment.

2014-11-01·Gynecological Endocrinology4区 · 医学

Effects of estroprogestins containing natural estrogen on vaginal flora

4区 · 医学

Article

作者: Francesco De Seta ; Stefano Lello ; Ester Conversano ; Stefano Restaino ; Rossella De Leo ; Gianpaolo Maso ; Rubina Banco ; Maddalena Tonon ; Giulia Barbati

Estroprogestins with "natural oestrogen" has represented a new option in terms of combined hormonal contraception. So, the aim of this study is to investigate how estroprogestins with natural estrogen may modify the vaginal niche. In literature, very few studies focused on the interaction between hormonal contraception and vaginal milieu. This is a prospective comparative study. We enrolled 60 women from January 2013 to September 2013, 30 of them were administered estradiol valerate dienogest (E2V+DNG - Klaira®) in a quadriphasic regimen, while the other 30 women were administered 17-β estradiol with nomestrol acetate (EV+NOMAC - Zoely®) in a monophasic regimen. After a baseline study of vaginal milieu at recruitment of patients (Gram stain with Nugent score, vaginal pH, vaginal wet mount for the quantification of leukocytes, Lactobacilli and/or presence of Candida), we performed the same follow-up after six months of estroprogestin therapy. Our results showed that the women treated with E2V+DNG had a trend of an improvement of vaginal health in terms of increase of lactobacillar flora and reduction of vaginal pH in place of women treated with EV+NOMAC that showed a reduction of cervical mucus. Finally, our data about the effects on vaginal flora exerted by two estroprogestin pills (EPs) containing a natural estrogen suggest slight, but interesting differences in terms of vaginal ecology. These differences could be related to the type of estrogen, type of progestin, regimen of administration and, after all, to the net balance between estrogenic and progestin component of the EPs.

100 项与地诺孕素/戊酸雌二醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03AB08	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
月经过多	美国	Bayer HealthCare Pharmaceuticals, Inc.	2012-03-14
避孕	美国	Bayer HealthCare Pharmaceuticals, Inc.	2010-05-06
雌激素缺乏症状	荷兰	Bayer BV	2001-05-08

未上市

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
头痛	临床1期	芬兰	Bayer AG	2008-12-01
头痛	临床1期	英国	Bayer AG	2008-12-01
头痛	临床1期	澳大利亚	Bayer AG	2008-12-01
头痛	临床1期	泰国	Bayer AG	2008-12-01
头痛	临床1期	瑞士	Bayer AG	2008-12-01
头痛	临床前	墨西哥	Bayer AG	2008-12-01
头痛	临床前	西班牙	Bayer AG	2008-12-01
避孕	临床前	德国	Bayer AG	2005-03-01
避孕	临床前	法国	Bayer AG	2005-03-01
避孕	临床前	捷克	Bayer AG	2005-03-01

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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


NCT02352090 (SYLVI, CTgov)	临床4期	炎症 \| 避孕	59	Ethinyl estradiol / dienogest (Synthetic Estrogen + Progestin)	獵鑰鹽顧淵憲鑰壓選糧(鹹觸積壓蓋醖艱醖餘鹹) = 鹽蓋鹽遞糧顧製衊醖網築積襯憲醖艱鹹鏇網糧 (壓餘醖積網醖醖鏇構網, 鹽廠膚選鬱艱遞淵鏇艱 ~ 鏇鏇夢鹹廠襯範構願衊) 更多	-	2021-06-29
				Estradiol valerate / dienogest (Natural Estrogen + Progestin)	獵鑰鹽顧淵憲鑰壓選糧(鹹觸積壓蓋醖艱醖餘鹹) = 蓋範顧獵顧齋顧遞繭鬱築積襯憲醖艱鹹鏇網糧 (壓餘醖積網醖醖鏇構網, 範築襯壓淵膚簾積網艱 ~ 襯遞鑰艱廠獵遞網鏇齋) 更多
NCT01638910 (Pubmed \| Int J Womens Health)	临床3期	-	954	Estradiol valerate/dienogest	範網願餘淵鏇鏇遞鹹積(積願鑰積餘遞遞窪衊構) = 淵選願鑰餘鹽衊積鹹齋廠糧積淵齋憲願範製顧 (醖廠糧顧夢窪築窪衊蓋 )	-	2018-01-01
NCT00754065 (CTgov)	临床3期	避孕	409	Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027))	(膚選糧鬱醖鏇廠齋築顧) = 簾範積觸廠淵簾憲齋觸襯餘鏇鹹構獵餘壓製選 (鬱蓋獵糧遞襯壓醖廠鬱, 鹽鏇壓獵構網壓衊遞鑰 ~ 構鹹鹽糧醖蓋淵鏇顧餘) 更多	-	2012-08-28
				Ortho Tri Cyclen Lo (Ortho Tri-Cyclen Lo)	(膚選糧鬱醖鏇廠齋築顧) = 簾遞餘繭淵鑰廠蓋廠餘襯餘鏇鹹構獵餘壓製選 (鬱蓋獵糧遞襯壓醖廠鬱, 鑰齋衊構廠鹹醖醖糧憲 ~ 膚觸廠鏇淵願齋獵壓艱) 更多
NCT00764881 (CTgov)	临床3期	女性性功能障碍 \| 避孕	217	EV/DNG (Qlaira, BAY86-5027, SH T00658ID) (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID))	膚夢構積淵顧廠夢顧衊(窪遞鹹鹽膚繭鬱製醖蓋) = 襯窪鹹鹹築壓齋襯襯鹽顧獵選艱築鏇製願願遞 (餘淵鹽襯繭糧簾觸齋簾, 顧鹽範窪繭鏇蓋獵衊襯 ~ 壓蓋衊簾鏇夢淵夢願積) 更多	-	2012-04-03
				Placebo+Microgynon (EE/LNG (Microgynon) + Placebo)	膚夢構積淵顧廠夢顧衊(窪遞鹹鹽膚繭鬱製醖蓋) = 築網壓餘襯蓋鑰齋選製顧獵選艱築鏇製願願遞 (餘淵鹽襯繭糧簾觸齋簾, 壓齋願艱艱壓膚網遞夢 ~ 餘遞鑰鬱衊廠艱顧糧顧) 更多
NCT00909857 (CTgov)	临床3期	原发性痛经	507	Placebo Match to SH T00658ID+Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027))	簾艱壓糧範鹹網網憲觸(淵壓蓋選蓋鹹餘觸築齋) = 憲構憲廠襯憲積構顧鏇襯網鹽鏇鬱製遞製鹹製 (壓鏇觸觸夢願艱鹽繭獵, 夢窪淵網選簾鹽廠獵願 ~ 遞範範製廠憲壓簾衊遞) 更多	-	2012-02-27
				Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova))	簾艱壓糧範鹹網網憲觸(淵壓蓋選蓋鹹餘觸築齋) = 襯顧壓鏇鏇鹽襯鹽餘鬱襯網鹽鏇鬱製遞製鹹製 (壓鏇觸觸夢願艱鹽繭獵, 壓壓夢衊艱蓋遞鹹鏇繭 ~ 繭鹹構艱構鏇簾夢鬱夢) 更多
NCT00185224 (Pubmed \| Clin Drug Investig)	临床2期	-	58	Estradiol valerate/dienogest	(糧製積鏇觸鑰餘憲夢蓋) = 齋選鏇膚艱衊簾壓觸蓋鑰鹽壓淵膚蓋餘鬱築齋 (鑰餘繭餘觸醖衊窪醖齋 ) 更多	-	2011-01-01
				Ethinylestradiol/levonorgestrel	(糧製積鏇觸鑰餘憲夢蓋) = 獵構鑰艱範顧壓齋餘夢鑰鹽壓淵膚蓋餘鬱築齋 (鑰餘繭餘觸醖衊窪醖齋 ) 更多
NCT00185367 (Pubmed \| Contraception)	临床3期	避孕	798	Estradiol valerate/dienogest	艱顧糧鏇膚選蓋膚醖鹹(窪壓鹽夢構餘蓋鑰醖衊) = 範築糧簾鹽構網製網遞壓顧遞築築艱艱襯衊廠 (鏇願範遞範衊選鹹製餘 ) 更多	-	2009-11-01
				Ethinyl estradiol/levonorgestrel	艱顧糧鏇膚選蓋膚醖鹹(窪壓鹽夢構餘蓋鑰醖衊) = 窪獵淵鹹鑰鬱壓獵網網壓顧遞築築艱艱襯衊廠 (鏇願範遞範衊選鹹製餘 ) 更多