Ethinylestradiol

Overview

Ethinylestradiol was first synthesized in 1938 by Hans Herloff Inhoffen and Walter Hohlweg at Schering. It was developed in an effort to create an estrogen with greater oral bioavailability. These properties were achieved by the substitution of an ethinyl group at carbon 17 of estradiol. Ethinylestradiol soon replaced mestranol in contraceptive pills. Ethinylestradiol was granted FDA approval on 25 June 1943.

Indication

Ethinylestradiol is combined with other drugs for use as a contraceptive, premenstrual dysphoric disorder, moderate acne, moderate to severe vasomotor symptoms of menopause, prevention of postmenopausal osteoporosis.

Associated Conditions

Menopausal Osteoporosis
Mild to Moderate Acne
Premenstrual Dysphoric Disorder (PMDD)
Moderate Acne vulgaris
Moderate, severe, Vasomotor Symptoms caused by Menopause

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis	2020/02/05	NCT04256200	Phase 2	UNKNOWN	American University of Beirut Medical Center
Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy（LLLT） for Primary Dysmenorrhea（PD）	2019/05/17	NCT03953716	Phase 4	UNKNOWN	Peking Union Medical College Hospital
OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol	2019/03/20	NCT03881904	Phase 1	UNKNOWN	Ain Shams University
Continuous Versus Cyclical OCP Use in PCOS	2019/01/28	NCT03819140	Phase 4	Completed	University of California, San Francisco
Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT	2018/05/21	NCT03531437	Phase 4	Terminated	Mahidol University
A Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Participants With B Cell Malignancy	2017/10/04	NCT03301207	Phase 1	Completed	Janssen Research & Development, LLC
Treatment Choice in Primary Dysmenorrhea	2017/04/24	NCT03124524	Phase 4	Completed	Adana Numune Training and Research Hospital
Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri	2017/01/31	NCT03037944	Early Phase 1	UNKNOWN	Ain Shams Maternity Hospital
A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone	2016/01/12	NCT02652650	Phase 1	Completed	Janssen Research & Development, LLC
Phlebotomy and Polycystic Ovary Syndrome	2015/06/02	NCT02460445	Not Applicable	Completed	Manuel Luque Ramírez

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Norethindrone Acetate and Ethinyl Estradiol	Glenmark Pharmaceuticals Inc., USA	68462-132	ORAL	0.02 mg in 1 1	6/22/2022
Junel FE	Direct_Rx	72189-215	ORAL	20 ug in 1 1	10/6/2022
Etonogestrel and Ethinyl Estradiol Vaginal	AvKARE	42291-478	VAGINAL	0.015 mg in 1 d	9/21/2023
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	0378-7280	ORAL	0.02 mg in 1 1	9/6/2017
Etonogestrel and Ethinyl Estradiol Vaginal Ring	Northstar Rx LLC	16714-029	VAGINAL	0.015 mg in 1 d	7/1/2023
norelgestromin and ethinyl estradiol	Zydus Pharmaceuticals USA Inc.	70710-1190	TRANSDERMAL	35 ug in 1 mg	9/16/2023
Norethindrone Acetate and Ethinyl Estradiol	Nivagen Pharmaceuticals, Inc.	75834-130	ORAL	0.005 mg in 1 1	8/22/2022
LUIZZA 1/20	Xiromed, LLC	70700-313	ORAL	0.02 mg in 1 1	4/21/2025
Amethyst	Actavis Pharma, Inc.	52544-295	ORAL	20 ug in 1 1	12/31/2021
NuvaRing	Organon LLC	78206-146	VAGINAL	0.015 mg in 1 d	1/9/2023

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
JASTINDA FILM COATED TABLETS 3MG/ 0.02MG	Laboratorios León Farma S.A	SIN14995P	TABLET, FILM COATED	0.02 mg	4/28/2016
BELARA film-coated tablet 0.03mg/2mg	Gedeon Richter Plc.	SIN14870P	TABLET, FILM COATED	0.030 mg	10/14/2015

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APO-DROSPIRENONE/EE 3/30 drospirenone 3 mg and ethinylestradiol 30 microgram film-coated tablet blister pack	195217	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/3/2013
LOETTE ethinylestradiol / levonorgestrel tablet blister pack	296338	Pfizer Australia Pty Ltd	Medicine	A	1/23/2018
ROSIE ethinylestradiol/drospirenone 20 microgram/3 mg tablet blister pack	407771	Lupin Australia Pty Limited	Medicine	A	9/14/2023
Desogestrel Ethinylestradiol-DWRN desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack	426652	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/12/2024
LEVLEN ED tablet blister pack	40193	Bayer Australia Ltd	Medicine	A	6/18/1992
LOGYNON ED tablet blister pack	40192	Bayer Australia Ltd	Medicine	A	6/18/1992
YASMIN ethinylestradiol 30 micrograms / drospirenone 3 mg film coated tablet blister pack	226238	Bayer Australia Ltd	Medicine	A	8/4/2014
APOTEX-DROSPIRENONE/EE 3/30 drospirenone 3 mg and ethinylestradiol 30 microgram film-coated tablet blister pack	195218	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/3/2013
TYRA-35 ED cyproterone acetate 2 mg, ethinylestradiol 35 microgram tablet blister pack	303989	Strides Pharma Science Pty Ltd	Medicine	A	9/3/2018
ROSALEE 3 mg/30 micrograms drospirenone/ethinylestradiol 3 mg/30 micrograms tablet blister pack	407772	Lupin Australia Pty Limited	Medicine	A	9/14/2023

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SYNPHASIC-28 TABLETS	syntex inc.	00695734	Tablet - Oral	.035 MG / TAB	12/31/1986
ORTHO 0.5/35 TABLETS (21 DAY)	Janssen Inc	00317047	Tablet - Oral	.035 MG	12/31/1974
MYA	Apotex Inc	02415380	Tablet - Oral	0.02 MG	5/20/2014
TRI-CYCLEN LO (21 DAY)	Janssen Inc	02258560	Tablet - Oral	0.025 MG	1/27/2005
SELECT 1/35 (28-DAY)	Pfizer Canada Ulc	02199297	Tablet - Oral	0.035 MG	5/1/1997
TEVA-CYPROTERONE / ETHINYL ESTRADIOL	teva canada limited	02309556	Tablet - Oral	0.035 MG	9/26/2008
SEASONALE	teva canada limited	02296659	Tablet - Oral	0.03 MG	1/3/2008
SARENSIS 21	Janssen Inc	02411466	Tablet - Oral	0.035 MG	N/A
PREVIFEM (28DAY)	novopharm limited	02320088	Tablet - Oral	0.035 MG	N/A
YASMIN PLUS	Bayer Inc	02442744	Tablet - Oral	0.03 MG	N/A

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CECILIANA DIARIO 2 MG/0,03 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sandoz Farmaceutica S.A.	78552	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
DESOGESTREL/ETINILESTRADIOL ARISTO 0,15 MG/0,02 MG COMPRIMIDOS EFG	Aristo Pharma Iberia S.L.	83128	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
GYNEPLEN 2 mg/0,035 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Laboratorios Effik S.A.	68256	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
DOLNA 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL EFG	Laboratorios Cinfa S.A.	82175	SISTEMA DE LIBERACIÓN VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
CLORMADINONA/ETINILESTRADIOL STADAFARMA 2 mg/0,03 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	86159	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETINILESTRADIOL/DROSPIRENONA DIARIO STADA 0,03 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	76059	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ETINILESTRADIOL/CLORMADINONA STADA 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	75288	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
GESTINYL 20/75 microgramos COMPRIMIDOS RECUBIERTOS	Laboratorios Effik S.A.	68671	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
LINELLE 0,1mg/0,02mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Theramex Ireland Limited	71708	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
BELARA DIARIO 2 MG/0,03 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Gedeon Richter Plc.	71898	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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