Delving into the Latest Updates on Drospirenone/Ethinyl Estradiol with Synapse

主要研究目的：在健康受试者体内，餐后状态下，以Bayer Australia Ltd持证，Bayer Weimar GmbH und Co.KG生产的屈螺酮炔雌醇片（II）（商品名：优思悦，规格：屈螺酮3 mg和炔雌醇0.02 mg）为参比制剂，研究浙江爱生药业有限公司研制的屈螺酮炔雌醇片（II）（受试制剂，规格：炔雌醇0.020 mg和屈螺酮3.000 mg）的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main study objectives: In healthy subjects, in the postprandial state, using Drospirenone Ethinyl Estradiol Tablets (II) (trade name: Yousiyue, specification: 3 mg drospirenone and 0.02 mg ethinyl estradiol) produced by Bayer Weimar GmbH und Co.KG and licensed by Bayer Australia Ltd as the reference preparation, to study the absorption rate and extent of Drospirenone Ethinyl Estradiol Tablets (II) (test preparation, specification: 0.020 mg ethinyl estradiol and 3.000 mg drospirenone) developed by Zhejiang Aisheng Pharmaceutical Co., Ltd., and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary study objectives: Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date12 Apr 2025

Sponsor / Collaborator

Zhejiang Aisheng Pharmaceutical Co. Ltd.

CTR20250804

/ Active, not recruitingNot Applicable

评估屈螺酮炔雌醇片(II)（规格：屈螺酮3 mg和炔雌醇0.02 mg）受试制剂与参比制剂在健康成年女性参与者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation of drospirenone ethinyl estradiol tablets (II) (strength: drospirenone 3 mg and ethinyl estradiol 0.02 mg) and the reference formulation in healthy adult female participants in the fed state

主要试验目的：研究餐后状态下单次口服受试制剂屈螺酮炔雌醇片(II)（规格：屈螺酮3 mg和炔雌醇0.02 mg；武汉九珑人福药业有限责任公司生产）与参比制剂屈螺酮炔雌醇片(II)（规格：屈螺酮3 mg和炔雌醇0.02 mg；Bayer Weimar GmbH & Co. KG生产）在健康成年女性参与者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂屈螺酮炔雌醇片(II)（规格：屈螺酮3 mg和炔雌醇0.02 mg）和参比制剂屈螺酮炔雌醇片（规格：屈螺酮3 mg和炔雌醇0.02 mg）在健康成年女性参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation drospirenone ethinylestradiol tablets (II) (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg; produced by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.) and the reference preparation drospirenone ethinylestradiol tablets (II) (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg; produced by Bayer Weimar GmbH & Co. KG) in healthy adult female participants after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary purpose of the study is to study the safety of the test preparation drospirenone ethinylestradiol tablets (II) (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg) and the reference preparation drospirenone ethinylestradiol tablets (specifications: drospirenone 3 mg and ethinylestradiol 0.02 mg) in healthy adult female participants.

Start Date03 Apr 2025

Sponsor / Collaborator

Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Drospirenone/Ethinyl Estradiol

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100 Translational Medicine associated with Drospirenone/Ethinyl Estradiol

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100 Patents (Medical) associated with Drospirenone/Ethinyl Estradiol

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295

Literatures (Medical) associated with Drospirenone/Ethinyl Estradiol

01 Oct 2024·European Journal of Obstetrics & Gynecology and Reproductive Biology

Safety assessment of Yasmin: Real-world adverse event analysis using the FAERS database

Article

Author: Wang, Jiahui ; Shi, Lingli ; Wang, Lihong ; Tang, Xiuqin ; 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.

01 Mar 2024·Heliyon

Comparing the risk of deep vein thrombosis of two combined oral contraceptives: Norethindrone/ethinyl estradiol and drospirenone/ethinyl estradiol

Article

Author: 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.

04 Jul 2023·Acta clinica Belgica

Inconsistencies in laboratory investigations of hypertension in a young woman taking ethinylestradiol/drospirenone association

Article

Author: 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.

1

News (Medical) associated with Drospirenone/Ethinyl Estradiol

27 Oct 2009

·www.pharmatimes.com

Bayer earnings fall again but pharma sales are healthy

Bayer has posted a decline in earnings and sales for the third quarter this morning, but pharmaceuticals continued to perform well as the German firm’s CropScience unit dragged the figures down. Net income fell 10.1% to 249 million euros, a less dramatic decline than expected by analysts, while group turnover was down 7.0% to 7.39 billion euros. However, sales at Bayer’s healthcare division were up 3.5% to 3.94 billion euros, helped by a favourable currency impact, while pharmaceutical revenues increased 3.0% to 2.55 billion euros. Growth was driven by Betaferon/Betaseron (interferon beta 1b) for multiple sclerosis (283 million euros; -2.7%) and the Yasmin (ethinyl estradiol/drospirenone) contraceptive franchise which climbed 3.9% to 320 million euros. Mirena, the firm’s levonorgestrel-releasing intrauterine contraceptive system, contributed 105 million euros, flat on the like, year-earlier period. The haemophilia agent Kogenate (recombinant antihaemophilic factor), edged up 5.1% to 247 million euros, while Nexavar (sorafenib), which is approved for liver as well as advanced kidney cancer, contributed 161 million euros, up 33.1%. Sales of the hypertension treatment Adalat (nifedipine) were up 4.7% to 155 million euros and the erectile dysfunction drug Levitra (vardenafil) climbed 12.2% to 92 million euros. As for Bayer’s antibiotics, Cipro/Ciprobay (ciprofloxacin) brought in 83 million euros, down 1.2%, while Avelox (moxifloxacin) fell 8.9% to 92 million euros. Chairman Werner Wenning said the group achieved a slight year-on-year increase in underlying profits for the first time this year and said “we are very pleased to have reversed the earnings trend despite the fact that many industries are still suffering from the economic crisis”. He added that Bayer is “still adhering to our ambitious full-year forecast” of 31- 32 billion euros in sales and limiting the decline in earnings before interest, taxes, depreciation and amortisation and special items, to 5%. The company plans to complete its current restructuring programmes by the end of 2009, and estimates the special charges involved in that process will reach 350 million euros, up from a previous estimate of 250 million euros.

100 Deals associated with Drospirenone/Ethinyl Estradiol

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dysmenorrhea	Japan	Bayer AG	15 May 2019
Endometriosis	Japan	Bayer AG	19 Dec 2016
Premenstrual Dysphoric Disorder	United States	Bayer HealthCare	04 Oct 2006
Contraception	Austria	Bayer BV	08 Aug 2000
Contraception	Belgium	Bayer BV	08 Aug 2000
Contraception	Bulgaria	Bayer BV	08 Aug 2000
Contraception	Croatia	Bayer BV	08 Aug 2000
Contraception	Cyprus	Bayer BV	08 Aug 2000
Contraception	Czechia	Bayer BV	08 Aug 2000
Contraception	Denmark	Bayer BV	08 Aug 2000
Contraception	Estonia	Bayer BV	08 Aug 2000
Contraception	Finland	Bayer BV	08 Aug 2000
Contraception	France	Bayer BV	08 Aug 2000
Contraception	Germany	Bayer BV	08 Aug 2000
Contraception	Greece	Bayer BV	08 Aug 2000
Contraception	Hungary	Bayer BV	08 Aug 2000
Contraception	Iceland	Bayer BV	08 Aug 2000
Contraception	Ireland	Bayer BV	08 Aug 2000
Contraception	Italy	Bayer BV	08 Aug 2000
Contraception	Latvia	Bayer BV	08 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary dysmenorrhea	Phase 3	Germany	Bayer AG	01 Dec 2007
Primary dysmenorrhea	Phase 3	United Kingdom	Bayer AG	01 Dec 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02710708 \| CTR20160203 (Pubmed \| Adv Ther)	Phase 4	-	1,921	YAZ (3 mg drospirenone/20 μg ethinyl estradiol)	rycdqthysv(cuefrcwief) = trtaftnvdr jzfgpkjtor (yfeffsbwyq )	-	01 Feb 2020
NCT00633360 (CTgov)	Not Applicable	Premenstrual Syndrome	32	Drospirenone and ethinyl estradiol (Drospirenone and Ethinyl Estradiol)	lpwbhmdvjf(najhpebign) = hmstcngijm dghikcnotj (uagceshify, exqlcdwrzv - zfotnulixc) View more	-	20 Mar 2017
				Placebo (Placebo)	lpwbhmdvjf(najhpebign) = chzgtukqaf dghikcnotj (uagceshify, syvuuarqhq - mxtwcggwdd) View more
NCT00442689 (CTgov)	Not Applicable	Metabolic Syndrome \| Polycystic Ovary Syndrome	97	ethinyl estradiol+drospirenone (Oral Contraceptive - 1)	fcxtlvpbuv(trkmqgrpor) = ioimttyudq jfdmxdwtsx (bavouqzguj, 17) View more	-	06 Jun 2014
				Flutamide - 2 (Flutamide - 2)	fcxtlvpbuv(trkmqgrpor) = aocemqktir jfdmxdwtsx (bavouqzguj, 14) View more
NCT00567164 (CTgov)	Phase 3	Contraception	1,887	EE20/DRSP (BAY86-5300) (Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300))	painrgkdjx(cjejebghlm) = mgharbxxwy tvjlwwbvwq (cqkpkwemqd, zgrciqjslg - soorzqgaru) View more	-	12 Mar 2014
				EE20/DRSP (BAY86-5300) (Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300))	qeroinxlfa(nnqzfihbmy) = ufqlhmqboe siyfvrfwpc (ocsasbbxol, 33.1) View more
NCT00722800 (CTgov)	Phase 2	Hidradenitis Suppurativa	4	Ethinyl Estradiol (YAZ)+Drospirenone (Drospirenone and Ethinyl Estradiol (YAZ))	apzployzga(ykomjyardv) = phumuvlrzo gsishzngpz (yguxcvqqfo, 2.1213) View more	-	16 Jan 2014
				Placebo (Placebo Tablets)	apzployzga(ykomjyardv) = ekbmxzwtjr gsishzngpz (yguxcvqqfo, 33.9411) View more
NCT00722761 (CTgov)	Phase 3	Acne Vulgaris	30	drospirenone and ethinyl estradiol (Drosperinone and Ethinyl Estradiol)	mmjlaonysb(ykkdwgadra) = pstupqztee yoeeqpetnx (fjxqxjokdb, 43.3) View more	-	05 Mar 2013
				Placebo tablet (Placebo Tablet)	mmjlaonysb(ykkdwgadra) = ockznqtpiw yoeeqpetnx (fjxqxjokdb, 77.6) View more
NCT00567164 (Pubmed \| Contraception)	Phase 3	-	1,864	Flexible(MIB) regimen	usyggodzrc(xuoqrmlpdr) = ksubecbbhu xpcqeqceyk (eekuknggkn, ±30) View more	-	01 Aug 2012
				Flexible(APC) regimen	usyggodzrc(xuoqrmlpdr) = vaeztujlas xpcqeqceyk (eekuknggkn, ±33)
NCT00283816 (CTgov)	Phase 3	Polycystic Ovary Syndrome \| Obesity	36	Metformin (Metformin)	qyvtkwxjtr(wcjcnoghzp) = oovtygobkb mrhsipumaj (ntxmdzhaxq, 8.6) View more	-	13 Jul 2011
				placebo (Placebo)	qyvtkwxjtr(wcjcnoghzp) = iapxteaucf mrhsipumaj (ntxmdzhaxq, 10.9) View more
NCT00818519 (CTgov)	Phase 3	Acne Vulgaris	179	Drospirenone+YAZ (EE20/Drospirenone (YAZ, BAY86-5300))	qjqjfdilyr(ebhqlgghsr) = dvuiaxkesg cjpmjkzolo (kytzrkrmqv, 31.45) View more	-	09 Jun 2011
				Placebo (Placebo)	qjqjfdilyr(ebhqlgghsr) = jywwotjtti cjpmjkzolo (kytzrkrmqv, 118.73) View more
NCT01258660 (CTgov)	Phase 1	Contraception	172	folic acid placebo+EE 0.03 mg/DRSP 3 mg (Yasmin) (EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo)	zglrojyikl(zjcfmhgspm) = dacmfnbwfp mbcjwrrkcu (ckpiwjwrtx, srccazjrfc - pkusvrfnxu) View more	-	13 May 2011
				folic acid+EE 0.03 mg/DRSP 3 mg (Yasmin) (EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid)	zglrojyikl(zjcfmhgspm) = fmbxczyfxg mbcjwrrkcu (ckpiwjwrtx, wnwqbdbjhh - svqiwwyxmn) View more