雌二醇/左炔诺孕酮(Estradiol/Levonorgestrel) - 药物靶点：ER x PR_在研适应症：绝经期后骨质疏松，血管疾病，血管舒缩症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Climara Pro、Fem7 Combi

+ [3]

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

心血管疾病内分泌与代谢疾病皮肤和肌肉骨骼疾病

在研适应症

绝经期后骨质疏松血管疾病血管舒缩症

非在研适应症-

原研机构

Bayer AG

在研机构

Berlex Laboratories, Inc.

Bayer HealthCare Pharmaceuticals, Inc.

Bayer Yakuhin Ltd.

+ [1]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2003-11-21),

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C39H52O4

InChIKeyRQFMPXMLRRPOJH-ORADRBJOSA-N

CAS号88873-29-4

关联

7

项与雌二醇/左炔诺孕酮相关的临床试验

NCT06455969 / Recruiting临床4期IIT

Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training

Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.
The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.

开始日期2024-07-15

申办/合作机构

University of Pittsburgh

[+1]

NCT02393482 / Unknown status临床4期IIT

Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study

The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.

开始日期2021-06-01

申办/合作机构

University of Cagliari

NCT02475265 / Completed临床2期IIT

Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.
This study will investigate whether the use of transdermal estrogen can improve bone mineral density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when used for 6 months.

开始日期2015-07-01

申办/合作机构

The General Hospital Corp.

[+1]

100 项与雌二醇/左炔诺孕酮相关的临床结果

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100 项与雌二醇/左炔诺孕酮相关的转化医学

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100 项与雌二醇/左炔诺孕酮相关的专利（医药）

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6

项与雌二醇/左炔诺孕酮相关的文献（医药）

2020-02-01·Cryobiology3区 · 生物学

A non-activating diluent to prolong in vitro viability of Apis mellifera spermatozoa: Effects on cryopreservation and on egg fertilization

3区 · 生物学

Article

作者: Rajamohan, Arun ; Rinehart, Joseph P ; Danka, Robert G ; Hopkins, Brandon K

A non-activating semen diluent does not cause motility or acrosomal reaction or capacitate the sperm cell. The effects of such a diluent on the viability of honey bee spermatozoa stored in ambient conditions were assessed 60 days pre-cryopreservation and 24 h post-cryopreservation. Seven variations of a Tris-based non-activating diluents (FEM1 - FEM7) were compared to samples treated with conventional activating diluent and untreated semen. Semen viability (membrane integrity) was assessed after short- and long-term storage at 14.0 ± 0.2 °C. The non-activating medium FEM7 contained more viable spermatozoa than the activating medium, 24 h after cryopreservation (67.6 ± 10.9% and ~4%, respectively). After 60 days, 22.0 ± 7.8% of spermatozoa was viable in non-activating medium versus 0.0 and 60.8 ± 12.3%, in conventional media and untreated controls, respectively. Hence FEM7 was used to cryopreserve bee semen and subsequently inseminate honey bee queens. The quality of brood produced by the queens was assessed 30-60 days after insemination. The percentage of worker-bee offspring (produced from successfully fertilized eggs) was ~75% for both the non-activating medium and the conventional extender medium. Our results indicate that a non-activating medium possesses significant advantage over the conventional activating medium if the semen requires storage after treatments such as cryopreservation. The percentage of female offspring (from fertilized eggs) produced by queens inseminated with semen diluted in either the activating or non-activating medium did not differ from one another.

2008-08-01·BJU International2区 · 医学

Early hormonal data from a multicentre phase II trial using transdermal oestrogen patches as first‐line hormonal therapy in patients with locally advanced or metastatic prostate cancer

2区 · 医学

Article

作者: Rachel C Morgan ; Noel W Clarke ; Paul D Abel ; Stuart D Rosen ; Philip Pollock ; Ruth E Langley ; Mahesh K B Parmar ; David P Dearnaley ; Howard Kynaston ; El-Nasir Lalani ; Roger Kockelbergh ; Ian F Godsland

OBJECTIVETo assess the hormonal effects of Fem7® (Merck, KGaA, Darmstadt, Germany) 100 µg transdermal oestrogen patches on men undergoing first‐line androgen‐deprivation therapy for prostate cancer.PATIENTS AND METHODSPATCH is a multicentre, randomized, phase II trial for men with locally advanced or metastatic prostate cancer, comparing luteinizing hormone‐releasing hormone agonist therapy with oestrogen patches. To assess the dosing schedule for the patches, as this was the first time that this brand of patch had been used in men, and to reassure patients and participating clinicians, the Independent Data Monitoring Committee agreed to early release of hormonal data from this study.RESULTSOestradiol, testosterone and prostate‐specific antigen (PSA) levels are presented for the first group of 14 patients who received the patches (with 1 withdrawal) and for whom there were ≥12 weeks of follow‐up by March 2007. After 12 weeks, testosterone levels (nmol/L) in eight of the 13 patients were <1.7, two were 1.7–2 and three were >2. The median (range) serum oestradiol levels was 442 (52.1–1542) pmol/L and all patients had a PSA response, with eight having a PSA level of <4 ng/mL.CONCLUSIONThese results confirm that oestrogen patches produce castrate levels of testosterone and concomitant PSA responses. They also highlighted the potential differences between different brands of oestrogen patches, and the need to monitor hormonal response, toxicity and efficacy until more experience with oestrogen patches for this clinical indication is obtained. The number of patches recommended in the PATCH study has now been increased.

2004-12-01·Expert Opinion on Pharmacotherapy3区 · 医学

17β-Estradiol/levonorgestrel transdermal system for the management of the symptomatic menopausal woman

3区 · 医学

Article

作者: Shulman, Lee P

Recent publications of the initial outcomes from the Women's Health Initiative (WHI) study of menopausal management have raised concerns over the safety of hormone therapy [1,2]. Every study, no matter how large or well conducted, has biases and limitations that preclude the ability to apply the outcomes to a larger group of individuals not specifically evaluated in the analysis. In particular, the hormonal arms of the WHI evaluated only a single dose of a daily oral regimen of conjugated equine oestrogen 0.625 mg [1,2], combined with medroxyprogesterone acetate 2.5 mg if the subject had a uterus [1]. The failure to evaluate non-oral regimens prevented the evaluation of hormone delivery systems that have been shown to provide similar symptom relief to oral regimens, but with a considerably different physiological impact. The once-weekly transdermal patch (Climara Pro releasing 17beta-estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day has been shown to be highly effective in rapidly reducing the frequency and intensity of vasomotor symptoms and to significantly improve all categories in the quality of life Women's Health Questionnaire [3]. In addition, this transdermal combination system was not associated with any cases of endometrial hyperplasia, adverse impacts on cholesterol or lipid values and was associated with an increasing rate of amenorrhoea over time [3]. The 17beta-estradiol/levonorgestrel transdermal system is approved in the US for the treatment of moderate-to-severe vasomotor symptoms and the prevention and treatment of urogenital atrophy.

100 项与雌二醇/左炔诺孕酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03F	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
绝经期后骨质疏松	美国	Berlex Laboratories, Inc.	2005-12-27
血管疾病	美国	Schering AG	2005-12-27
血管舒缩症	美国	Bayer HealthCare Pharmaceuticals, Inc.	2003-11-21

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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


NCT02475265 (1180, CTgov)	临床2期	骨质疏松症 \| 神经性厌食症	11	estradiol 0.045 mg/levonorgestrel 0.015mg	窪鬱鹽艱網壓顧壓壓選(選構網獵範衊膚繭衊鑰) = 醖廠餘憲廠艱蓋願築糧積構膚鹽膚築繭鏇夢壓 (觸鑰鹽鏇鹹鏇糧餘構廠, 壓淵築積獵顧鏇齋構鏇 ~ 製積艱膚窪艱夢衊構蓋) 更多	-	2019-07-22