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
Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)	2011/12/12	NCT01490190	Phase 4	Completed	Organon and Co
Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome	2011/10/25	NCT01459445	Not Applicable	UNKNOWN	Iuliu Hatieganu University of Medicine and Pharmacy
A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants	2011/10/24	NCT01458210	Phase 1	Completed	Eli Lilly and Company
New Treatments for Troublesome Bleeding in Implanon Users	2011/06/29	NCT01384331	Phase 4	UNKNOWN	Family Planning Association New South Wales
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon	2011/04/04	NCT01328184	Phase 1	Completed	Boehringer Ingelheim
NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment	2011/02/17	NCT01298128	Not Applicable	Terminated	University of Toronto
Evaluation of an Oral Contraceptive Containing 30 mg Ethinyloestradiol and 150 mg Desogestrel on Women's Health	2010/12/08	NCT01256619	Phase 2	UNKNOWN	Tehran University of Medical Sciences
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study	2010/12/06	NCT01254292	Phase 3	Completed	Bayer
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol	2010/11/18	NCT01243580	Phase 1	Completed	Agile Therapeutics
A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.	2010/09/06	NCT01195974	Phase 1	Terminated	ViiV Healthcare

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Junel 1.5/30	Physicians Total Care, Inc.	54868-6272	ORAL	30 ug in 1 1	4/16/2012
Norethindrone Acetate and Ethinyl Estradiol	Glenmark Pharmaceuticals Inc., USA	68462-657	ORAL	5 ug in 1 1	11/27/2023
MICROGESTIN 1/20	RPK Pharmaceuticals, Inc.	53002-1549	ORAL	20 ug in 1 1	9/30/2020
Etonogestrel and Ethinyl Estradiol	Teva Pharmaceuticals USA, Inc.	0093-7679	VAGINAL	0.015 mg in 1 d	9/30/2022
NuvaRing	Central Texas Community Health Centers	76413-131	VAGINAL	0.015 mg in 1 d	2/5/2016
Norelgestromin and Ethinly Estradiol	Amneal Pharmaceuticals NY LLC	69238-1521	TRANSDERMAL	35 ug in 1 d	12/30/2023
Aurovela 1.5/30	Aurobindo Pharma Limited	65862-935	ORAL	30 ug in 1 1	11/21/2023
Dolishale	Ingenus Pharmaceuticals, LLC	50742-659	ORAL	20 ug in 1 1	12/11/2020
Microgestin	Physicians Total Care, Inc.	54868-6213	ORAL	0.02 mg in 1 1	4/26/2012
EnilloRing	Xiromed, LLC	70700-156	VAGINAL	0.015 mg in 1 d	7/10/2023

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
No HSA approvals found for this drug.

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
YANA drospirenone 3 mg and ethinylestradiol 20 microgram film coated tablet blister pack	200633	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/15/2013
MADELINE desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack	202833	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/23/2013
AVA-35 ED cyproterone acetate 2 mg, ethinylestradiol 35 microgram tablet blister pack	303987	Strides Pharma Science Pty Ltd	Medicine	A	9/3/2018
PALANDRA ED ethinylestradiol 30 micrograms / drospirenone 3 mg film coated tablet blister pack	226239	Bayer Australia Ltd	Medicine	A	8/4/2014
YAZ drospirenone 3mg / ethinylestradiol 20 micrograms (as betadex clathrate) tablet blister pack	226241	Bayer Australia Ltd	Medicine	A	8/4/2014
TRIFEME ethinylestradiol/levonorgestrel tablet blister pack	40133	Pfizer Australia Pty Ltd	Medicine	A	6/5/1992
Microgynon 50 ED tablets blister pack	10695	Bayer Australia Ltd	Medicine	A	8/19/1991
Microgynon 30 ED tablet blister pack	10693	Bayer Australia Ltd	Medicine	A	8/19/1991
NORIMIN 28 Day tablet blister pack	62133	Pfizer Australia Pty Ltd	Medicine	A	1/8/1998
AMELIA-35 ED cyproterone acetate 2 mg, ethinylestradiol 35 microgram tablet blister pack	303986	Strides Pharma Science Pty Ltd	Medicine	A	9/3/2018

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRI-PREVIFEM (21 DAY)	novopharm limited	02320096	Tablet - Oral	0.035 MG	N/A
LAYLAA 28	lupin pharma canada limited	02424290	Tablet - Oral	20 MCG	7/6/2023
DIANE-35	Bayer Inc	02233542	Tablet - Oral	35 MCG	4/8/1998
ZARAH 21	Cobalt Pharmaceuticals Company	02385058	Tablet - Oral	0.03 MG	6/4/2013
TARO-CYPROTERONE/ETHINYL ESTRADIOL	sun pharma canada inc	02425017	Tablet - Oral	0.035 MG	3/26/2015
TRI-LENA 21	actavis pharma company	02443597	Tablet - Oral	0.035 MG	N/A
TRI-CIRA LO 28	Apotex Inc	02401975	Tablet - Oral	0.025 MG	6/9/2014
LOESTRIN 1.5/30	Allergan, Inc.	00353027	Tablet - Oral	30 MCG	12/31/1976
ORTHO-CEPT TABLETS (28 DAY)	Janssen Inc	02042533	Tablet - Oral	0.03 MG	12/31/1993
TRI-LENA 28	actavis pharma company	02443600	Tablet - Oral	0.035 MG	N/A

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
YASMIN DIARIO 3 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Bayer Ab	2000-02881IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
YASMINELLE 3 MG /0,02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Bayer Limited	PA1410024001IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
MICROGYNON 0,15 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS	Bayer	BE091235	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
TRIGYNOVIN comprimidos recubiertos	Bayer Portugal Lda.	8770107	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
YASMIN COMPRIMIDOS RECUBIERTOS	Bayer Hellas A.E.	3303827505	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
EVRA 203 MICROGRAMOS/24 HORAS + 33,9 MICROGRAMOS/24 HORAS PARCHE TRANSDERMICO	Gedeon Richter Plc.	02223002IP4	PARCHE TRANSDÉRMICO	Medicamento Sujeto A Prescripción Médica	Commercialized
YIRA 3 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Bayer Hispania S.L.	63577	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
MELIANE 0,075 mg / 0,02 mg COMPRIMIDOS RECUBIERTOS	Bayer	BE174124IP3	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
ETINILESTRADIOL/GESTODENO SANDOZ 0,02 mg/0,075 mg COMPRIMIDOS RECUBIERTOS	Sandoz Farmaceutica S.A.	70316	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
BELARA 0,03mg/2mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Gedeon Richter Plc.	5503487	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not 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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