美雌醇/炔诺酮(Mestranol/Norethindrone) - 药物靶点：PR_在研适应症：月经紊乱_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Sophia-A、Sophia-C

靶点

PR

作用方式

激动剂

作用机制

PR激动剂(孕激素受体激动剂)

治疗领域

其他疾病

在研适应症

月经紊乱

非在研适应症

避孕

原研机构

Ortho-McNeil Pharmaceutical LLC

在研机构

ASKA Pharmaceutical Co., Ltd.

非在研机构

Ortho-McNeil Pharmaceutical LLC

最高研发阶段批准上市

首次获批日期

美国 (1962-05-21),

避孕月经紊乱

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

结构/序列

分子式C20H26O2

InChIKeyVIKNJXKGJWUCNN-XGXHKTLJSA-N

CAS号68-22-4

查看全部结构式(2)

关联

2

项与美雌醇/炔诺酮相关的临床试验

NCT01044498

/ Completed临床3期

An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)

This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.

开始日期2009-12-01

申办/合作机构

Hoffmann-La Roche, Inc.

NCT00972439

/ CompletedN/AIIT

Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation

The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.

开始日期2007-08-01

申办/合作机构

University of Southern California

[+1]

100 项与美雌醇/炔诺酮相关的临床结果

登录后查看更多信息

100 项与美雌醇/炔诺酮相关的转化医学

登录后查看更多信息

100 项与美雌醇/炔诺酮相关的专利（医药）

登录后查看更多信息

43

项与美雌醇/炔诺酮相关的文献（医药）

2001-08-01·Regulatory Toxicology and Pharmacology4区 · 医学

Pharmacology and Toxicology of Ethinyl Estradiol and Norethindrone Acetate in Experimental Animals

4区 · 医学

Review

作者: William E. Maier ; James R. Herman

For over 30 years various combinations of synthetic estrogens and progestins have been used in oral contraceptive formulations. Ethinyl estradiol (EE) and norethindrone acetate (NA) are common synthetic hormones used in oral contraceptives such as Loestrin, Brevicon, Ortho-Novum, Norlestrin, and Norinyl. In recent years these oral contraceptives have been considered for development in other therapeutic indications. Given the use of these agents for other clinical indications with different and larger target populations, an updated comprehensive review of the toxicology literature of estrogens and progestins is warranted. This review will summarize available data on the pharmacology and toxicology of estrogens and progestins with an emphasis on the specific synthetic hormones EE and NA. Ethinyl estradiol and norethindrone acetate alone or in combination, possess low acute and chronic toxicity. In some studies, EE and/or NA increased the incidence of specific tumors in susceptible strains of rodents and dogs, but not monkeys. These agents are not teratogenic when given in combination. Alone EE and NA have clastogenic properties. Overall, the animal data demonstrates that long-term exposure to EE and NA formulations pose very little health risks to humans.

1991-11-01·Contraception2区 · 医学

A comparative study of 35 mcg and 50 mcg combined oral contraceptives: Results from a multicenter clinical trial

2区 · 医学

Article

作者: Dunson, B A ; Dunson, T R ; McLaurin, V L

A comparative multicenter clinical trial of two combined oral contraceptives (OCs) differing only in the estrogen content (35 mcg ethinyl estradiol versus 50 mcg mestranol) was conducted at five clinics located in Yugoslavia, Egypt, Sri Lanka, Costa Rica and Mexico. The trial was designed to determine the differences between Norinyl 1+35 (Syntex) and Norinyl 1+50 (Syntex) in rates and reasons of discontinuation, and frequency of selected side effects which might contribute to method discontinuation. This report includes analysis of 1698 women, all of whom were interval patients (at least 42 days but within 26 weeks postpartum), randomly allocated to one of the above OCs between October 1982 and January 1984. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Significantly more women in the Norinyl 1+35 group (p less than .001) reported intermenstrual bleeding (primarily staining and spotting), as well as an increase in the occurrence of intermenstrual bleeding compared to women in the Norinyl 1+50 group. There were no significant differences between the groups for side effects with the exception of more women in the Norinyl 1+50 group (p less than .05) reporting breast discomfort. The lost to follow-up rate at 12 months was 19.3% for both the Norinyl 1+35 and the Norinyl 1+50 groups. The total discontinuation rate (including women lost to follow-up) at 12 months was 43.5% for the Norinyl 1+35 group and 41.0% for the Norinyl 1+50 group. There were no significant differences between the two groups for gross cumulative life table discontinuation rates (p greater than .05). There were six accidental pregnancies attributed to user failure reported during the study period; four in the Norinyl 1+35 group and two in the Norinyl 1+50 group.

1990-06-01·Advances in Contraception

A comparative clinical trial of Norinyl 1+35 versus Norinyl 1+50 in Merida, Yucatan, Mexico

Article

作者: T. R. Dunson ; A. J. Rowan ; T. C. De Cetina ; C. S. Waszak ; L. P. Reyes ; M. B. Weaver ; L. V. Gamboa

A comparative clinical trial of two combined oral contraceptives differing only in estrogen type and dosage was conducted at the Centro de Investigaciones Hideyo Noguchi in Merida, Yucatan, Mexico. The trial was designed to determine the differences between Norinyl 1 + 50 (Syntex) and Norinyl 1 + 35 (Syntex) in rates of discontinuation and frequency of selected side-effects which might contribute to method discontinuation. Three hundred women were randomly assigned to either the Norinyl 1 + 35 group or to the Norinyl 1 + 50 group and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. In the Norinyl 1 + 35 group, more women experienced an increase in intermenstrual bleeding (primarily staining and spotting) (p less than 0.05), breast discomfort (p less than 0.05) and nausea than in the Norinyl 1 + 50 group. There was a significantly higher discontinuation rate for personal reasons, such as desired change of method and method not needed, among the women taking Norinyl 1 + 35 (p less than 0.05). The largest number of discontinuations comprised women discontinuing for menstrual problems in both groups. The life-table total discontinuation rate at 12 months was 52.0 for the Norinyl 1 + 35 group and 50.7 for the Norinyl 1 + 50 group. The lost-to-follow-up rates at 12 months were 17.8 for the Norinyl 1 + 35 group and 22.8 for the Norinyl 1 + 50 group.

100 项与美雌醇/炔诺酮相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	美雌醇/炔诺酮	G03FA01 G03FB05	-

研发状态

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
月经紊乱	日本	ASKA Pharmaceutical Co., Ltd.	1967-02-15

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00972439 (CTgov)	N/A	避孕	33	Oral Contraceptive: Ortho-Novum® 1/35 (Ortho-Novum® 1/35)	築艱鏇繭鹽範憲網製憲(艱顧鹽餘壓鏇構餘範廠) = 襯齋簾膚鏇鏇夢簾鑰窪觸築鏇淵糧鹹夢艱範製 (顧糧簾窪夢選壓壓衊選, 製築壓鬱積壓構構遞觸 ~ 糧觸構願糧願鹹淵繭壓) 更多	-	2018-02-23
				Oral Contraceptive: Ovcon Fe® (Ovcon Fe®)	築艱鏇繭鹽範憲網製憲(艱顧鹽餘壓鏇構餘範廠) = 築夢遞鬱窪鑰醖淵鑰齋觸築鏇淵糧鹹夢艱範製 (顧糧簾窪夢選壓壓衊選, 鹹醖選積簾窪鏇廠網夢 ~ 鏇鏇蓋鏇鏇築窪鏇簾鑰) 更多
NCT01044498 (CTgov)	临床3期	类风湿关节炎	46	tocilizumab+Ortho-Novum® 1/35 (Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1))	膚選構襯鬱積簾鹹鹽淵(窪窪範築鏇範艱鹽憲壓) = 鹹獵鹽衊蓋網網餘夢網積齋鬱鏇鑰網憲製網構 (憲蓋艱齋襯蓋憲糧獵鹹, 壓遞壓窪繭糧積積糧積 ~ 網積選艱蓋淵製艱鏇獵) 更多	-	2013-03-12
				Ortho-Novum® 1/35 (Ortho-Novum® 1/35 (Group 2))	膚選構襯鬱積簾鹹鹽淵(窪窪範築鏇範艱鹽憲壓) = 壓顧網遞製蓋願窪憲窪積齋鬱鏇鑰網憲製網構 (憲蓋艱齋襯蓋憲糧獵鹹, 鹽蓋顧衊襯鑰齋獵窪鬱 ~ 鬱構淵築膚艱衊鹹遞鏇) 更多