炔雌醇环丙孕酮(Cyproterone Acetate/Ethinylestradiol) - 药物靶点：AR x ER_在研适应症：寻常痤疮，妇女多毛症，前列腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Ethinylestradiol and Cyproterone Acetate、醋酸环丙孕酮/炔雌醇、Diane

+ [3]

靶点

AR x ER

作用方式

拮抗剂、激动剂

作用机制

AR拮抗剂(雄激素受体拮抗剂)、ERs激动剂(雌激素受体家族激动剂)

治疗领域

肿瘤内分泌与代谢疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

寻常痤疮妇女多毛症前列腺癌+ [1]

非在研适应症-

原研机构

Bayer AG

在研机构

Bayer Vital GmbH

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

中国 (2004-08-20),

寻常痤疮妇女多毛症前列腺癌+ [1]

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C44H53ClO6

InChIKeyRWYFURDDADFSHT-BGWUALDMSA-N

CAS号60528-19-0

关联

23

项与炔雌醇环丙孕酮相关的临床试验

CTR20240590

/ CompletedN/A

炔雌醇环丙孕酮片人体生物等效性研究

本试验旨在研究单次空腹和餐后口服浙江仙琚制药股份有限公司研制、生产的炔雌醇环丙孕酮片（炔雌醇0.035 mg + 醋酸环丙孕酮2 mg）的药代动力学特征；以Bayer Weimar GmbH und Co. KG生产的炔雌醇环丙孕酮片（达英-35®，炔雌醇0.035 mg + 醋酸环丙孕酮2 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

开始日期2024-02-26

申办/合作机构

浙江仙琚制药股份有限公司

NCT05657171

/ CompletedN/AIIT

"Effect of Cyproterone Acetate / Ethinyl Estradiol Combination on Periodontal Tissue and High Sensitivity C- Reactive Protein Levels in Women With Polycystic Ovary Syndrome Having Gingivitis."

PCOS is a widely reported condition among young female population and anti-androgen agents are increasingly being used as part of the medical management of such cases. However, Clinical studies have reported higher prevalence of gingival inflammation, loss of attachment and gingival enlargement in women taking hormone based oral contraceptives. Additionally, CPA has been reported to have an osteoclastic action. Therefore, it is necessary to explore the effects of these medications on the periodontal condition of PCOS patients having gingivitis, who already are pre-disposed to systemic inflammation. Therefore, the present study aims to longitudinally evaluate the effect of CPA/EE combination regimen on the periodontal status of female patients diagnosed with PCOS with pre-existing gingivitis..

开始日期2022-12-12

申办/合作机构

Postgraduate Institute of Dental Sciences Rohtak

NCT05316935

/ Recruiting临床2/3期IIT

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

开始日期2022-07-13

申办/合作机构

复旦大学

100 项与炔雌醇环丙孕酮相关的临床结果

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100 项与炔雌醇环丙孕酮相关的转化医学

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100 项与炔雌醇环丙孕酮相关的专利（医药）

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356

项与炔雌醇环丙孕酮相关的文献（医药）

2025-02-01·Journal of Ethnopharmacology

Treatment of Qin Gui Wan (QGW) in PCOS abnormal oocytes development via AMPK/PGC-1ɑ pathway

Article

作者: Zhang, Shujing ; Cui, Yiwei ; Zhang, Chuxin ; Cheng, Yuli ; Yang, Chenyu ; Gao, Lin ; Li, Xiaojuan ; Yu, Xue ; Zang, Weiyu

OBJECTIVESTo investigate the therapeutic effects of Qin Gui Wan (QGW) and its disassembled functional drug groups, Wenyang Zhuhuo (WYZH) and Xinwen Zhuyang (XWZY), on letrozole-induced PCOS rats.METHODSPCOS rat model was established by administering letrozole for 21 days. The rats were divided into control, PCOS, Diane-35, QGW, WYZH and XWZY groups. The changes of body weight, ovarian coefficient, estrous cycle and sex hormone levels were observed. The ovarian histological characteristics and ovulation were observed by HE staining. P450arom, SF-1, and AMPK/PGC-1ɑ pathway mRNA and protein expression were analyzed using qRT-PCR, WB, and IHC. The AMPK inhibitor Compound C (CC) was used to explore the treatment mechanism of QGW in granulosa cells. And UHPLC-MS/MS was used to performed chemical composition analysis.RESULTSQGW, WYZH, and XWZY can correct the disordered estrous cycle of PCOS rats and improve the serum hormone status of rats to varying degrees. HE results indicated that QGW, WYZH, and XWZY improved ovarian polycystic changes and normalized ovulation. qRT-PCR, WB, and IHC results demonstrated that QGW, WYZH, and XWZY increased PGC-1α, SF-1, and P450arom mRNA and protein expression in the ovaries of PCOS rats. The level of AMPK mRNA in the ovaries of QGW and its disassembled prescriptions increased, while only WYZH and XWZY rats showed increased ovarian AMPK levels. CC attenuated the activation of AMPK, PGC-1α, SF-1, and P450arom mRNA by QGW.CONCLUSIONSThis study demonstrates that QGW alleviates abnormal oocyte development in PCOS rats, possibly by enhancing P450arom expression via the AMPK/PGC-1α pathway, thus restoring normal androgen-estrogen balance and follicular development.

2024-12-31·Gynecological Endocrinology

Comparative effects of the antioxidant glutathione with metformin and Diane-35 on hormonal, metabolic, and inflammatory indicators in a DHEA-induced PCOS rat model

Article

作者: Timur, Hikmet Tunç ; Tanoglu, Fatma Basak ; Özkara, Gülçin ; Tok, Olgu Enis ; Çetin, Çağlar ; Coşar, Aslı ; Neccar, Duygu ; Özcan, Pınar

OBJECTIVEComparison of hormonal, metabolic and inflammatory markers of glutathione with metformin and Diane-35 in a rat model of PCOS induced by dehydroepiandrosterone.METHODSTwenty-five female rats were randomized into four groups. Group 1 was administered a subcutaneous dose of 0.2 ml saline/day. Group 2 was given 0.2 ml of 1% carboxymethyl cellulose (CMC)/day orally for 28 days. A PCOS model was established with DHEA in rats. Group 3 was given 4.5 mg/kg/day of Diane-35 orally dissolved in 1% CMC for 28 days. Group 4 was given 300 mg/kg/day of metformin orally dissolved in 1 ml of saline for 28 days, and Group 5 was administered 100 mg/kg of glutathione intraperitoneally on days 35, 42, and 49. On day 56, the rats were sacrificed. Serum markers and follicle count were examined.RESULTSSerum IL-6, hs-CRP, insulin, testosterone, SHBG, and MDA values were significantly lower in the glutathione group than in the PCOS group (p = 0.0006, p = 0.023, p = 0.0082, p = 0.0007, p = 0.0048, and p < 0.0001, respectively).The number of all follicles was similar between the control and glutathione groups (p < 0.05). When we compared the other groups with the PCOS group, the number of primary, secondary, atretic, and cystic follicles was significantly lower in the metformin and glutathione groups. The number of primordial and antral follicles was significantly higher than in the PCOS group.CONCLUSIONSGlutathione plays anti-inflammatory and antioxidant roles, similar to metformin, by lowering serum IL-6, insulin, testosterone, CRP, and MDA levels; decreasing atretic/cystic follicle count; and improving antral follicle count and folliculogenesis in PCOS patients.

2024-09-01·Heliyon

Efficacy and safety of cangfu daotan decoction as an adjuvant treatment of Diane-35 for polycystic ovary syndrome: A systematic review and meta-analysis

Article

作者: Xu, Sheng ; Cheng, Shaomin ; Feng, Xianjie ; Chen, Xin ; Zhou, Xu

ObjectiveCangfu Daotan decoction is a classic traditional Chinese medicine formula that has been found to be beneficial for treating polycystic ovarian syndrome (PCOS) in animal models. This systematic review aimed to assess the efficacy and safety of Cangfu Daotan decoction as an adjuvant treatment to Diane-35 for PCOS in humans.MethodsSeven electronic databases were searched up to June 22, 2024, to identify randomized controlled trials (RCTs) that evaluated Cangfu Daotan decoction combined with Diane-35 versus Diane-35 alone for the treatment of PCOS. The effects of individual RCTs were combined via meta-analysis and were measured as relative risks (RRs) or weighted mean differences (WMDs).ResultsTwenty-five RCTs with a moderate to high risk of bias were included, involving 1845 patients with PCOS. Meta-analyses indicated that compared with Diane-35 alone, the combination of Diane-35 and Cangfu Daotan decoction significantly improved the response rate (RR 1.19, 95 % confidence interval [CI] 1.14 to 1.24), pregnancy rate (RR 1.57, 95 % CI 1.18 to 2.09), ovulation rate (RR 1.22, 95 % CI 1.11 to 1.35), and ovarian volume (WMD -1.43 cm³, 95 % CI -2.46 to -0.39). Cangfu Daotan decoction also significantly reduced the luteinizing hormone (LH) level, LH:FSH ratio, testosterone level, prolactin level, body mass index (BMI) and hirsutism and acne scores but had no significant effect on the follicle-stimulating hormone (FSH) level. All adverse events were mild and not related to Cangfu Daotan decoction treatment.ConclusionsThe findings suggest that Cangfu Daotan decoction, as an adjuvant therapy to Diane-35 for the treatment of PCOS, can reduce multiple sex hormone levels and BMI, relieve hyperandrogenism signs, and ultimately improve pregnancy outcomes, with good safety. The effect of Cangfu Daotan decoction on FSH remains uncertain. Due to limitations of risk of bias and heterogeneity, the quality of evidence was rated as moderate to very low.

100 项与炔雌醇环丙孕酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03HB01	-

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
寻常痤疮	中国	Bayer Vital GmbH	2004-08-20
妇女多毛症	中国	Bayer Vital GmbH	2004-08-20
前列腺癌	中国	Bayer Vital GmbH	2004-08-20
性早熟	中国	Bayer Vital GmbH	2004-08-20

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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


NCT04964193 (CTgov)	N/A	-	24	Elzsa film-coated tablet (Elzsa Film-coated Tablet)	窪膚鏇鏇鑰鏇鏇鬱鹹鹽(觸艱蓋獵選襯築餘選簾) = 鹹餘鹽願齋鏇鹽糧衊網蓋齋襯鹹蓋餘顧鏇憲繭 (艱獵襯選夢選窪選顧選, 壓衊鏇齋夢簾積選顧襯 ~ 製襯餘窪壓鑰顧鏇繭鹹) 更多	-	2022-01-31
NCT04964193 (CTgov)	N/A	-	24	Diane-35 Sugar-coated tablet (Diane-35 Sugar-coated Tablet)	窪膚鏇鏇鑰鏇鏇鬱鹹鹽(觸艱蓋獵選襯築餘選簾) = 蓋壓積觸艱遞獵鹽築淵蓋齋襯鹹蓋餘顧鏇憲繭 (艱獵襯選夢選窪選顧選, 餘觸遞觸壓憲齋夢製廠 ~ 夢壓築顧範簾醖衊壓範) 更多	-	2022-01-31
NCT03264638 (Pubmed \| Chin J Integr Med)	临床2期	多囊卵巢综合征	117	Diane-35	糧鬱鏇網夢簾膚鏇選襯(壓鹹製憲鑰醖選淵鏇鹹) = 衊膚顧壓夢鹽衊糧襯遞鬱醖簾齋網鏇憲鏇鏇遞 (願簾糧廠鏇鑰獵夢顧憲 )	积极	2019-04-01