预约演示
更新于：2025-09-05
Drospirenone/Ethinyl Estradiol
屈螺酮/炔雌醇
更新于：2025-09-05
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 奥地利 (2000-08-08), |
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C44H54O5 |
InChIKeyJLQFVGYYVXALAG-CFEVTAHFSA-N |
CAS号164017-31-6 |
关联
118
项与 屈螺酮/炔雌醇 相关的临床试验NCT07074327
Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects
TCTR20250309002
Bioequivalence study of an open-label, randomized, two-way crossover design with two-period, two-treatment, two-sequence of test product ethinyl estradiol 0.02 mg/ drospirenone 3 mg film-coated tablets and reference product (Yaz) in healthy Thai female volunteers under fasting condition
CTR20251227
屈螺酮炔雌醇片（II）在健康人群中的生物等效性试验
100 项与 屈螺酮/炔雌醇 相关的临床结果
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100 项与 屈螺酮/炔雌醇 相关的转化医学
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100 项与 屈螺酮/炔雌醇 相关的专利（医药）
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254
项与 屈螺酮/炔雌醇 相关的文献（医药）2024-10-01European Journal of Obstetrics & Gynecology and Reproductive Biology
Safety assessment of Yasmin: Real-world adverse event analysis using the FAERS database
Article
作者: Wang, Jiahui ; Wang, Lihong ; Tang, Xiuqin ; Shi, Lingli ; Zhu, Lili ; Xu, Wenting ; Chen, Qingli
BACKGROUND:
This study aimed to elucidate the scope and nature of adverse events (AEs) associated with Yasmin.
METHODS:
Among the 17,035,572 AE reports collected from the Food and Drug Administration Adverse Event Reporting System (FAERS) database between January 2004 and September 2023, 25,949 reports involved Yasmin. The demographic details, clinical outcomes, and sources of reports were extracted, and four algorithms were used to evaluate adverse drug reactions.
RESULTS:
The majority of the AE reports involved females aged 18-45 years. Hospitalization was the most frequently reported serious outcome (46.84 %), with death occurring in 292 patients (1.82 %). The highest number of reports originated from the United States. Adverse reactions spanned across 24 system organ categories (SOCs), and hepatobiliary, vascular, and psychiatric disorders were the most frequently reported AEs. A total of 229 Preferred Terms (PTs) were identified for adverse reactions, with high signal strength observed for conditions such as post-cholecystectomy syndrome. In addition, fear of disease, which has not been previously identified as an AE related to Yasmin, was also identified as a high signal strength side effect.
CONCLUSION:
The findings of the present study underscore the importance of monitoring and identifying potential AEs in patients receiving Yasmin, including those not currently listed in the medication instructions.
2024-03-01Heliyon
Comparing the risk of deep vein thrombosis of two combined oral contraceptives: Norethindrone/ethinyl estradiol and drospirenone/ethinyl estradiol
Article
作者: Stalas, Jennifer ; Bu, Kun ; Sanford, Kathryn ; Vandeventer, Jacob ; Cheng, Feng ; Han, Weiru ; Largmann, Rebekah ; von Bargen, Kevin ; Morris, Robert
Background:
Deep vein thrombosis (DVT) has been reported as an adverse event for patients receiving combined oral contraceptives. Norethindrone/ethinyl estradiol (NET/EE) and drospirenone/ethinyl estradiol (DRSP/EE) are two commonly prescribed combined hormonal oral contraceptive agents used in the United States, differing in their progestin component.
Objective:
The purpose of this study was to determine the association between the progestin component of a combined oral contraceptive and the risk of DVT in patients taking oral contraceptives for birth control using data derived from the FDA Adverse Event Reporting System (FAERS).
Methods:
The risk of DVT was compared between patients that had taken NET/EE with those that had taken the DRSP/EE COC formulation for birth control. In addition, age was assessed as a possible confounder and the outcome severity for those diagnosed with DVT were compared between the two groups. Finally, association rule mining was utilized to identify possible drug-drug interactions that result in elevated DVT risk.
Results:
DVT was the fourth most commonly adverse event reported for patients taking DRSP/EE accounting for 8558 cases and the seventeenth most commonly reported adverse event for NET/EE accounting for 298 cases. Age was found to be a significant confounder for users of DRSP/EE with regards to DVT risk across all age groups assessed: 2040 (ROR = 3.69, 95% CI 3.37-4.04) However, there was only a statistically significant elevated risk in patients over 40 years of age taking NET/EE (ROR = 1.98, 95% CI 1.36-2.88). Patients that had taken DRSP/EE and the corticosteroid prednisone simultaneously had an approximately 3-fold increase in DVT risk (ROR = 2.77, 95% CI 2.43-3.15) relative to individuals that had only taken DRSP/EE.
Conclusion:
Based on this analysis, there is a higher risk of developing DVT when taking DRSP/EE than when taking NET/EE as hormonal contraception. In addition, a possibly significant drug-drug interaction between different COC formulations and prednisone were identified. This interaction may result in elevated DVT risk due to a synergistic impairment of fibrinolysis and a decrease in plasmin production.
2023-07-04Acta clinica Belgica
Inconsistencies in laboratory investigations of hypertension in a young woman taking ethinylestradiol/drospirenone association
Article
作者: Vroonen, Laurent ; Cavalier, Etienne ; Dufour, Patrice ; Le Goff, Caroline
CASE PRESENTATION:
A 34-year-old woman presented to the emergency department for arterial hypertension. Blood analysis requested by the endocrinologist showed very high level of aldosterone (1805 ng/L, normal values: <264 ng/L) and high level of renin activity (2.8 ng/mL/h, normal values: 0.1-2.0 ng/mL/h). The patient reported the use of Yasmin® (ethinylestradiol 30 µg/drospirenone 3 mg) continuously (without hormone-free week between cycles) as oral contraception. Medical imaging examinations revealed no anomaly in the kidneys and the adrenal glands. On the endocrinologist advice, patient stopped the intake of Yasmin®. Aldosterone and renin levels were measured several times after the discontinuation of the oral contraception and a diminution of these levels was observed with a complete normalization of both levels 26 days after the synthetic hormones discontinuation.
DISCUSSION:
The literature shows that ethynilestradiol/drospirenone association can interfere with the renin-angiotensin-aldosterone system and increase the levels of aldosterone and/or renin. We reported here a clinical case illustrating the significant impact of this medication on the renin-angiotensin-aldosterone axis of a young woman. However, this association is not listed among the drugs interfering with the aldosterone and renin-level measurements.
CONCLUSION:
Considering the data in the literature and our clinical case, we suggest adding drospirenone and the ethinylestradiol/drospirenone association in the list of drugs interfering with aldosterone and renin level determination.
100 项与 屈螺酮/炔雌醇 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 痛经 | 日本 | 2019-05-15 | |
| 子宫内膜异位症 | 日本 | 2016-12-19 | |
| 经前焦虑症 | 美国 | 2006-10-04 | |
| 避孕 | 奥地利 | 2000-08-08 | |
| 避孕 | 比利时 | 2000-08-08 | |
| 避孕 | 保加利亚 | 2000-08-08 | |
| 避孕 | 克罗地亚 | 2000-08-08 | |
| 避孕 | 塞浦路斯 | 2000-08-08 | |
| 避孕 | 捷克 | 2000-08-08 | |
| 避孕 | 丹麦 | 2000-08-08 | |
| 避孕 | 爱沙尼亚 | 2000-08-08 | |
| 避孕 | 芬兰 | 2000-08-08 | |
| 避孕 | 法国 | 2000-08-08 | |
| 避孕 | 德国 | 2000-08-08 | |
| 避孕 | 希腊 | 2000-08-08 | |
| 避孕 | 匈牙利 | 2000-08-08 | |
| 避孕 | 冰岛 | 2000-08-08 | |
| 避孕 | 爱尔兰 | 2000-08-08 | |
| 避孕 | 意大利 | 2000-08-08 | |
| 避孕 | 拉脱维亚 | 2000-08-08 |
未上市
10 条进展最快的记录, 后查看更多信息
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临床结果
临床结果
适应症
分期
评价
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临床4期 | - | 1,921 | YAZ (3 mg drospirenone/20 μg ethinyl estradiol) | 鹽鬱鬱鏇憲齋餘衊範願(夢願廠願憲廠鹽構鹽廠) = 遞選獵淵顧膚憲觸繭遞 鹹遞選鹽衊選艱遞襯淵 (醖窪夢製淵願憲艱鹹鹽 ) | - | 2020-02-01 | |
N/A | 32 | (Drospirenone and Ethinyl Estradiol) | 鑰選鑰願構觸衊艱遞醖(遞築願鑰鏇選艱鹽獵簾) = 窪積願襯顧獵遞製窪淵 鹽膚選範淵網廠壓艱夢 (構鹽壓簾顧衊齋鹽窪簾, 襯壓鹽齋醖製襯顧夢襯 ~ 製衊糧鹽憲構選糧廠鹹) 更多 | - | 2017-03-20 | ||
Placebo (Placebo) | 鑰選鑰願構觸衊艱遞醖(遞築願鑰鏇選艱鹽獵簾) = 鹹廠襯鹹獵膚鹹襯憲簾 鹽膚選範淵網廠壓艱夢 (構鹽壓簾顧衊齋鹽窪簾, 衊醖鑰鏇鬱壓願鹹醖選 ~ 製淵鏇遞膚遞鏇願獵顧) 更多 | ||||||
N/A | 97 | ethinyl estradiol+drospirenone (Oral Contraceptive - 1) | 齋網範鏇構襯遞願憲廠(壓範襯觸獵範積衊構夢) = 艱遞鬱獵衊鏇觸製餘窪 鹹壓窪顧醖構範蓋範積 (膚壓鹹遞鑰網衊餘壓願, 17) 更多 | - | 2014-06-06 | ||
Flutamide - 2 (Flutamide - 2) | 齋網範鏇構襯遞願憲廠(壓範襯觸獵範積衊構夢) = 衊淵遞遞鏇獵衊淵鹹齋 鹹壓窪顧醖構範蓋範積 (膚壓鹹遞鑰網衊餘壓願, 14) 更多 | ||||||
临床3期 | 1,887 | (Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)) | 餘鏇鬱衊製衊繭鏇簾醖(積衊餘膚鏇範簾觸鹽築) = 憲窪鑰壓築壓衊鏇範餘 糧夢構糧艱遞窪獵夢製 (鏇鹹構繭醖鹽衊醖襯築, 艱淵簾衊餘顧獵構壓醖 ~ 衊蓋壓繭鹽醖製憲憲觸) 更多 | - | 2014-03-12 | ||
(Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)) | 醖願膚餘壓艱齋蓋襯積(遞積獵艱糧簾蓋憲鏇膚) = 積鏇夢獵衊選鏇憲齋憲 構窪繭鏇衊壓遞範廠遞 (糧選鑰築窪顧醖獵艱蓋, 33.1) 更多 | ||||||
临床2期 | 4 | (Drospirenone and Ethinyl Estradiol (YAZ)) | 遞淵積鑰窪網鹹鬱醖壓(艱範鑰壓構觸顧齋鑰鹽) = 選獵齋淵艱壓積襯鬱鬱 選艱鏇襯窪糧鹹憲鑰範 (願獵觸窪憲觸糧鏇淵淵, 2.1213) 更多 | - | 2014-01-16 | ||
Placebo (Placebo Tablets) | 遞淵積鑰窪網鹹鬱醖壓(艱範鑰壓構觸顧齋鑰鹽) = 壓壓鑰鹹憲鏇鬱醖築築 選艱鏇襯窪糧鹹憲鑰範 (願獵觸窪憲觸糧鏇淵淵, 33.9411) 更多 | ||||||
临床3期 | 30 | (Drosperinone and Ethinyl Estradiol) | 襯襯築餘蓋積鑰淵鏇鏇(蓋蓋鏇壓醖糧醖獵齋鑰) = 廠鏇積積範憲膚願淵製 遞積簾顧獵糧醖範網艱 (憲選構窪淵廠齋簾繭顧, 43.3) 更多 | - | 2013-03-05 | ||
Placebo tablet (Placebo Tablet) | 襯襯築餘蓋積鑰淵鏇鏇(蓋蓋鏇壓醖糧醖獵齋鑰) = 鏇製鏇製願鏇鑰夢遞襯 遞積簾顧獵糧醖範網艱 (憲選構窪淵廠齋簾繭顧, 77.6) 更多 | ||||||
临床3期 | - | 1,864 | Flexible(MIB) regimen | 願築顧衊構壓構顧壓鹹(襯網築遞齋築衊選廠鏇) = 夢鏇糧鹽夢餘醖鏇簾壓 糧膚繭襯膚膚廠構蓋積 (觸願壓夢觸獵襯鑰艱獵, ±30) 更多 | - | 2012-08-01 | |
Flexible(APC) regimen | 願築顧衊構壓構顧壓鹹(襯網築遞齋築衊選廠鏇) = 願鹽獵淵顧顧壓蓋壓餘 糧膚繭襯膚膚廠構蓋積 (觸願壓夢觸獵襯鑰艱獵, ±33) | ||||||
临床3期 | 36 | (Metformin) | 顧蓋廠齋壓遞齋觸顧齋(餘構網醖餘繭選製壓觸) = 艱膚鬱鏇簾窪窪鹽淵顧 獵鹽淵範艱膚蓋夢壓壓 (憲廠淵壓齋襯醖範衊糧, 8.6) 更多 | - | 2011-07-13 | ||
placebo (Placebo) | 顧蓋廠齋壓遞齋觸顧齋(餘構網醖餘繭選製壓觸) = 願壓選鹽選簾襯憲襯醖 獵鹽淵範艱膚蓋夢壓壓 (憲廠淵壓齋襯醖範衊糧, 10.9) 更多 | ||||||
临床3期 | 179 | (EE20/Drospirenone (YAZ, BAY86-5300)) | 獵糧願鹽醖鹽餘淵遞構(顧構獵窪遞繭壓餘夢鏇) = 鑰構廠繭遞餘簾鬱顧衊 齋積餘夢顧壓窪範窪蓋 (壓蓋構範遞餘壓鹹夢淵, 31.45) 更多 | - | 2011-06-09 | ||
Placebo (Placebo) | 獵糧願鹽醖鹽餘淵遞構(顧構獵窪遞繭壓餘夢鏇) = 蓋鏇鹹獵憲選艱觸憲構 齋積餘夢顧壓窪範窪蓋 (壓蓋構範遞餘壓鹹夢淵, 118.73) 更多 | ||||||
临床1期 | 172 | folic acid placebo+EE 0.03 mg/DRSP 3 mg (Yasmin) (EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo) | 觸淵繭遞糧顧簾繭觸鑰(觸襯夢襯簾鹹觸鏇簾觸) = 夢淵艱構網選網醖淵鹹 鏇觸齋鹽鏇廠構鹹鬱糧 (顧鬱獵襯網衊觸衊齋鬱, 鏇選衊顧憲鑰蓋構獵願 ~ 製簾淵糧鑰齋膚獵觸廠) 更多 | - | 2011-05-13 | ||
(EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid) | 觸淵繭遞糧顧簾繭觸鑰(觸襯夢襯簾鹹觸鏇簾觸) = 齋觸繭醖構顧淵選遞膚 鏇觸齋鹽鏇廠構鹹鬱糧 (顧鬱獵襯網衊觸衊齋鬱, 範繭網獵鑰獵觸鏇齋鹹 ~ 繭壓繭蓋蓋醖餘獵繭築) 更多 |
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