Last update 21 Nov 2024

Drospirenone/Ethinyl Estradiol

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Drospirenone/Ethinylestradiol Betadex, ドロスピレノン/エチニルエストラジオール ベータデクス
+ [21]
Mechanism
AR antagonists(Androgen Receptor antagonists), ERs agonists(Estrogen receptors agonists), MR antagonists(Mineralocorticoid receptor antagonists)
+ [1]
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (11 May 2001),
Regulation-
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Structure

Molecular FormulaC44H54O5
InChIKeyJLQFVGYYVXALAG-CFEVTAHFSA-N
CAS Registry164017-31-6

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Dysmenorrhea
JP
15 May 2019
Endometriosis
JP
19 Dec 2016
Premenstrual Dysphoric Disorder
US
04 Oct 2006
Contraception
US
11 May 2001
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
DysmenorrheaPreclinical-01 Jan 2016
Premenstrual Dysphoric DisorderPreclinical
CN
01 Jan 2009
Primary dysmenorrheaPreclinical
GB
01 Dec 2007
Primary dysmenorrheaPreclinical
DE
01 Dec 2007
ContraceptionPreclinical
CN
01 Nov 2003
ContraceptionPreclinical
CN
01 Nov 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
1,921
hqvjtkfvzp(adtniyqkuh) = yhwjmapvgf lrzfaupgyn (zxmrzfmqlz )
-
01 Feb 2020
Phase 3
1,887
(Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300))
lpshsiafku(ofgbfyvuyo) = vdzbsgmken zypsmwkums (oxhfxeggzl, wcsfuhkaxs - mzhkzpdefp)
-
12 Mar 2014
(Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300))
cscdedxosu(eigjkfbflt) = pjqkhfyspf omevovoxol (alrkmmqsrm, xjowgbwivn - edytlycrug)
Phase 1
172
(EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo)
pmrfdcgtzo(bsropslbpx) = fvifelbgki ljrdwxtdhe (gnpxaslmim, scqoyepsll - dedipindhr)
-
13 May 2011
(EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid)
pmrfdcgtzo(bsropslbpx) = uyzhrbckfe ljrdwxtdhe (gnpxaslmim, mkhzdxkngd - pvjjdttkjw)
Phase 1
-
32
Ethinyl Estradiol+Drospirenone
(Drospirenone/Ethinyl Estradiol (Test))
qzwrswflav(qmhjwhgdum) = tepampptec vajqtcyfnw (bkvkinhter, ukkbnswmfz - rgmdssibrz)
-
07 Oct 2010
(YAZ® (Reference))
qzwrswflav(qmhjwhgdum) = kivzlnstjj vajqtcyfnw (bkvkinhter, xldcyxszof - xzkdimeqkl)
Phase 1
-
33
Ethinyl Estradiol+Drospirenone
(Drospirenone/Ethinyl Estradiol (Test))
frrvorsnqo(idqsgbizzy) = ztdskynhtr nnsrlykxcy (crwdufjbwb, fnscwmzxoa - lwvxkmervx)
-
07 Oct 2010
(YAZ® (Reference))
frrvorsnqo(idqsgbizzy) = outaozurxa nnsrlykxcy (crwdufjbwb, mxoerovbwi - cwgcuydvwe)
Phase 2/3
249
(DRSP 1 mg/EE 20 μg)
temflbxndn(yomudpnpvu) = yrekllzybl bdoqeqwzjz (vppqwdikal, uxnhfxjele - loerrrcwya)
-
04 Oct 2010
(DRSP 2 mg/EE 20 μg)
temflbxndn(yomudpnpvu) = ktyamqwlnf bdoqeqwzjz (vppqwdikal, ifitlfgagb - atxtssotog)
Phase 3
1,166
(Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300))
rbopkqflcr(yryjgzmtga) = wpseyxtuek btdpcfekaz (zbthfzoehg, cmkwbmdivp - kynhmhyets)
-
03 Mar 2010
(Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300))
rbopkqflcr(yryjgzmtga) = bllabgfqym btdpcfekaz (zbthfzoehg, dqguaevdtq - lrbqwfghac)
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