醋酸甲羟孕酮/环戊丙酸雌二醇(Estradiol Cypionate/Medroxyprogesterone Acetate) - 药物靶点：ER x PR_在研适应症：怀孕_专利_临床

概要

基本信息

药物类型

小分子化药

别名

CycloProvera、Cyclofem、Esprova

+ [7]

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

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

Pharmacia & Upjohn, Inc.

最高研发阶段批准上市

首次获批日期

越南 (1998-10-06),

怀孕

最高研发阶段(中国)-

特殊审评-

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结构

分子式C50H70O7

InChIKeyNEDJKVIUOSOCNB-AWPSVMBFSA-N

CAS号71615-27-5

关联

12

项与醋酸甲羟孕酮/环戊丙酸雌二醇相关的临床试验

NCT04710017 / CompletedN/AIIT

Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial

Abnormal uterine bleeding is a symptom and not a disease. It is one of the most frequently encountered complaints in gynecologic practice. It accounts for more than 70% of all gynecological consultations in the peri- and post-menopausal age group.
Abnormal uterine bleeding may be acute or chronic and is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy.
Chronic heavy or prolonged uterine bleeding can result in anemia, interfere with daily activities. Iron deficiency anemia develops in 21 to 67 percent of cases and raises concerns about uterine cancer.
According to the International Federation of Obstetrics and Gynecology, the classification of abnormal uterine bleeding is based on PALM-COEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN).

开始日期2021-02-01

申办/合作机构

Assiut University

NCT03792477 / Completed临床1期

A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS

This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.

开始日期2019-01-19

申办/合作机构

Pfizer Inc.

NCT03443089 / Completed临床1期IIT

Comparative Bioavailability Study of Two Injectable Suspension Formulations, a Test (Medroxyprogesterone Acetate 25 mg/mL + Estradiol Cypionate 5 mg/mL) vs. a Reference (Medroxyprogesterone Acetate 25 mg/AMP + Estradiol Cypionate 5 mg/AMP)

This clinical trial evaluated the comparative bioavailability of two injectable suspension formulations of medroxyprogesterone acetate + estradiol cypionate, a test (Depomês®, 25 mg/mL medroxyprogesterone acetate + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.) and a reference formulation (Cyclofemina®, 25 mg/0.5 mL medroxyprogesterone acetate + 5 mg/0.5 mL estradiol cypionate, Millet Roux Ltda.) in healthy female volunteers after a single intramuscular dose administration. In addition, this study also evaluated the safety and tolerability of these drugs.

开始日期2017-03-31

申办/合作机构

BIOLAB SANUS Farmacêutica Ltda.

100 项与醋酸甲羟孕酮/环戊丙酸雌二醇相关的临床结果

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100 项与醋酸甲羟孕酮/环戊丙酸雌二醇相关的转化医学

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100 项与醋酸甲羟孕酮/环戊丙酸雌二醇相关的专利（医药）

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83

项与醋酸甲羟孕酮/环戊丙酸雌二醇相关的文献（医药）

2014-01-01·Journal of Advanced Pharmaceutical Technology & Research

Comparing the satisfaction and efficacy of Cyclofem and contraceptive pills among females in Northern Iran: A randomized controlled trial study

Article

作者: Kazeminavaei, Fatemeh ; Firoozbakht, Mozhgan ; Kiapoor, Azade ; Taghlili, Fatemeh ; Jamali, Bita

Hormonal contraceptives are the most effective method for birth control, though they may have some default or complications. This research aimed to comparison of the efficacy and satisfaction of Cyclofem with oral contraceptives (OCs) among females. A descriptive-comparative method was conducted on 80 women who were selected through cluster sampling during November 2011-December 2012. The selected subjects start using OCs or Cyclofem for the 1(st) time in their life. They evaluated in 2 times frames, at the beginning of the study and then 3 and 6 months after the contraceptive precautions. The data were collected by questionnaire. The data were analysed using parametric and nonparametric test in SPSS 16 software. The reasons for discontinuation of the methods were varied, in which 50% of the sample group were Cyclofem users who discontinued because of menstrual changes and the desire to use other methods, and 50% were the OC users whose reason was medical problems, and absent-mindedness was the last reason for 35.7% of the cases. The efficacy of the both (OCs and Cyclofem) was high and only one unwanted pregnancy occurred at the end of the 6(th) month among OC users. There was no significant difference in term of satisfaction of two groups at the end of 3-6 months (PV = 0.433). The results indicated that Cyclofem can be well used by those women who desire for an easy and effective method which is not disturbing the sexual activity and does not also need to be used daily, but the users should be consulted before using the method.

2013-09-01·Journal of family & reproductive health

Comparison of Two Different Injectable Contraceptive Methods: Depo-medroxy Progesterone Acetate (DMPA) and Cyclofem.

Article

作者: Veisi, Firoozeh ; Zangeneh, Maryam

OBJECTIVETo compare side effects between users of two kinds of injectable contraceptives (Depo-medroxy progesterone acetate and Cyclofem).MATERIALS AND METHODSThis cross-sectional descriptive study included 250 women, aged 18-40 years, using Depo-medroxy progesterone acetate (DMPA) or Cyclofem. The volunteers were examined six months after using contraceptive, and they were asked about following symptoms: weight changes, irregular bleeding, dysparounia, vaginal dryness, headache, breast pain, bone pain, and discontinuation reason. The data were analyzed by statistical methods.RESULTSTHE IMPORTANT SIDE EFFECTS OF DMPA WERE: irregular bleeding (93.60%), weight gain (48%), bone pain (24%) and vaginal dryness (10.40%), while the side effects in the Cyclofem group were: irregular bleeding (65.60%), headache (14.4%) and breast sensitivity (20%). Bleeding pattern changes were the most important problem leading to discontinuation of both contraceptive methods in our participants.CONCLUSIONThe results of the study showed that the most important problem in both groups was change in bleeding pattern. Proper consulting by a trained expert reduces the high amount of discontinuation and their failure rates.

2013-06-01·Contraception2区 · 医学

Medroxyprogesterone acetate and estradiol cypionate injectable suspension (Cyclofem) monthly contraceptive injection: steady-state pharmacokinetics

2区 · 医学

Article

作者: David F. Archer ; Andrea Thurman ; Peter Hall ; Thomas Kimble ; Jill L. Schwartz

BACKGROUNDCyclofem is a combined injectable contraceptive, containing medroxyprogesterone acetate (MPA) and estradiol cypionate. The objective was to characterize the steady-state pharmacokinetics (PK) using tandem liquid chromatography/mass spectrometry and compare these data to a previous PK study of this formulation in US women.STUDY DESIGNFifteen ovulatory, surgically sterile women received three Cyclofem injections, once every 28 days, with serum PK measurements on 23 separate days. Trough levels of estradiol and MPA were obtained on Days 1, 29 and 57, prior to each of the three injections. Steady-state concentrations of MPA and estradiol were assessed during the third treatment month on Days 58, 60, 62, 64, 67, 69, 71, 75, 78 and 85. MPA and serum progesterone levels were measured during the follow-up phase to assess MPA clearance (Days 92, 99, 106, 113, 120, 127, 134 and 141) and return of ovulation (Days 103, 106, 131 and 134).RESULTSIn the steady state, mean serum MPA concentrations peaked at 1.31 ng/mL at 4.1 days. Mean estradiol levels peaked at 254 pg/mL by 3.3 days. Ovulation was suppressed for at least 77 days post third injection in all but one woman.CONCLUSIONSOnce monthly injections of Cyclofem resulted in contraceptive levels of MPA without accumulation of hormones, consistent with a previous US study.

100 项与醋酸甲羟孕酮/环戊丙酸雌二醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	醋酸甲羟孕酮/环戊丙酸雌二醇	G03CA	-

研发状态

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适应症	国家/地区	公司	日期
怀孕	越南	Pfizer Inc.	1998-10-06

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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


NCT01699022 (CTgov)	临床1/2期	避孕	17	Injection Cyclofem	廠繭製壓廠夢夢遞獵鑰(夢鹹壓襯襯鹽顧壓鹽夢) = 鏇願鹽築廠觸範築鬱淵繭夢艱構鏇膚鏇獵齋鬱 (壓構願膚觸築願繭簾鑰, 顧齋獵壓艱觸鬱觸製襯 ~ 憲積築願窪鹽夢夢鬱窪) 更多	-	2013-12-30
ChiCTR-ONRC-14004419 (Pubmed \| Fertil Steril)	N/A	卵巢过度刺激综合征	155	Study group (hMG and MPA)	衊壓窪築廠醖鏇齋衊鬱(鬱糧鬱簾壓餘憲廠襯醖) = 襯膚簾築範齋製糧鬱遞構觸顧鬱願構壓製艱窪 (網積積窪艱簾積簾積構 ) 更多	-	2015-07-01
ChiCTR-ONRC-14004419 (Pubmed \| Fertil Steril)	N/A	卵巢过度刺激综合征	155	Medroxyprogesterone acetate (Control group (short protocol))	衊壓窪築廠醖鏇齋衊鬱(鬱糧鬱簾壓餘憲廠襯醖) = 構願膚觸鑰選窪積範鹹構觸顧鬱願構壓製艱窪 (網積積窪艱簾積簾積構 ) 更多	-	2015-07-01