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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/02 | Not Applicable | Completed | |||
2024/05/02 | Not Applicable | Completed | |||
2024/03/22 | Phase 4 | Completed | |||
2023/11/24 | Phase 3 | Completed | |||
2023/11/15 | N/A | Active, not recruiting | |||
2023/09/15 | Phase 1 | Completed | |||
2023/07/07 | Phase 1 | Terminated | |||
2023/01/31 | Phase 1 | Completed | Janssen Pharmaceutica N.V., Belgium | ||
2021/07/22 | Phase 1 | Completed | |||
2021/04/05 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0555-9027 | ORAL | 30 ug in 1 1 | 8/14/2023 | |
| Agile Therapeutics, Inc. | 71671-100 | TRANSDERMAL | 2.30 mg in 1 1 | 9/11/2020 | |
| Teva Pharmaceuticals USA, Inc. | 0555-9025 | ORAL | 20 ug in 1 1 | 8/14/2023 | |
| A-S Medication Solutions | 50090-5611 | VAGINAL | 0.015 mg in 1 d | 1/9/2023 | |
| Bryant Ranch Prepack | 72162-2220 | TRANSDERMAL | 35 ug in 1 d | 1/5/2024 | |
| A-S Medication Solutions | 50090-1008 | VAGINAL | 0.015 mg in 1 d | 1/24/2020 | |
| Physicians Total Care, Inc. | 54868-4832 | VAGINAL | 2.7 mg in 1 1 | 2/9/2012 | |
| Teva Pharmaceuticals, Inc. | 0480-3472 | ORAL | 20 ug in 1 1 | 3/6/2023 | |
| Prasco Laboratories | 66993-605 | VAGINAL | 0.015 mg in 1 d | 1/13/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3122 | ORAL | 5 ug in 1 1 | 2/27/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/22/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GVEZA FILM COATED TABLETS 3MG/ 0.03MG | SIN14996P | TABLET, FILM COATED | 0.03 mg | 4/28/2016 | |
| MICROGYNON 30 TABLET | SIN04834P | TABLET, SUGAR COATED | 0.03 mg | 6/26/1990 | |
| YASMIN TABLET | SIN12334P | TABLET, FILM COATED | 0.03 mg | 6/25/2003 | |
| LIZA FILM-COATED TABLETS 3MG/0.03MG | SIN14894P | TABLET, FILM COATED | 0.03mg | 11/13/2015 | |
| ESTELLE-35 TABLET | SIN12117P | TABLET, FILM COATED | 0.035 mg | 10/31/2002 | |
| ESTELLE-35ED TABLET | SIN11974P | TABLET, FILM COATED | 0.035 mg | 6/4/2002 | |
| EVRA TRANSDERMAL PATCH (6 mg/600 mcg) | SIN12423P | PATCH | 600 mcg/patch | 9/17/2003 | |
| DIANE-35 TABLET | SIN04784P | TABLET, SUGAR COATED | 0.035 mg | 6/11/1990 | |
| MERCILON TABLET | SIN06136P | TABLET | 0.02 mg | 6/19/1991 | |
| DROSPERA FILM-COATED TABLETS 3 MG/0.02 MG | SIN14855P | TABLET, FILM COATED | 0.02mg | 9/22/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HARMONET TAB | N/A | N/A | N/A | 2/19/1999 | |
| ELLANITE TABLETS 0.03MG/3MG | N/A | N/A | N/A | 6/25/2024 | |
| GVEZA TABLETS 3MG/0.03MG | N/A | N/A | N/A | 8/15/2016 | |
| NORDETTE TAB | N/A | N/A | N/A | 11/10/1978 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| YASMIN 21 | Bayer Inc | 02261723 | Tablet - Oral | 0.03 MG | 12/22/2004 |
| MARVELON 21 | organon canada inc. | 02042487 | Tablet - Oral | 0.03 MG | 12/31/1993 |
| QISMETTE 21 | 02416506 | Tablet - Oral | 0.030 MG | N/A | |
| YAZ | Bayer Inc | 02321157 | Tablet - Oral | 0.02 MG | 1/6/2009 |
| CENTRISA LO 21 | 02411431 | Tablet - Oral | 0.025 MG | N/A | |
| LOLO | 02417456 | Tablet - Oral | 10 MCG | 3/24/2014 | |
| ALESSE 21 | 02236974 | Tablet - Oral | 20 MCG | 1/7/1998 | |
| TRI-CIRA LO 21 | 02401967 | Tablet - Oral | 0.025 MG | 6/9/2014 | |
| PORTIA 21 | teva canada limited | 02295946 | Tablet - Oral | 0.03 MG | 8/14/2007 |
| PREVIFEM (21DAY) | novopharm limited | 02320061 | Tablet - Oral | 0.035 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ANTINELLE DIARIO 0,02 mg/3 mg COMPRIMIDOS CON PELICULA EFG | 76080 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| GRACIAL COMPRIMIDOS | 63034 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MELODENE-15 0,06 mg/ 0,015 mg COMPRIMIDOS RECUBIERTOS CON PELICULA. | Bayer Hispania S.L. | 63176 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CLEODETTE DIARIO 0,02 MG/3 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Aurovitas Spain, S.A.U. | 77123 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| YAZ 3 mg / 0,02 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Bayer Hispania S.L. | 70093 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| NUVARING 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL | Organon Salud S.L. | 64570 | SISTEMA DE LIBERACIÓN VAGINAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| EVRA 203 MICROGRAMOS/24 HORAS + 33,9 MICROGRAMOS/24 HORAS PARCHE TRANSDERMICO | 02223001IP3 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| DRETINELLE DIARIO 0.02 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 72035 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ETINILESTRADIOL/DROSPIRENONA EXELTIS 0,02 MG/3 MG COMPRIMIDOS RECUBIERTOS CON PELICULA (24+4) EFG | Exeltis Healthcare S.L. | 78405 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DROSPIRENONA/ETINILESTRADIOL ARISTO 3 MG/0,02 MG COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 80228 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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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