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 |
|---|---|---|---|---|---|
2003/01/27 | Phase 2 | Completed | |||
2002/08/01 | N/A | Completed | |||
2000/08/04 | Not Applicable | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| 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 |
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| 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 |
|---|---|---|---|---|---|
| NUVARING etonogestrel 11.7 mg and ethinylestradiol 2.7 mg vaginal drug delivery system | 381186 | Medicine | A | 3/29/2022 | |
| Desogestrel Ethinylestradiol-RJIC desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack | 426810 | Medicine | A | 3/12/2024 | |
| LEVETH 150/30 ED levonorgestrel 150 microgram and ethinylestradiol 30 microgram film-coated tablet blister pack | 425712 | Medicine | A | 1/8/2024 | |
| DIANE-35 ED tablet blister pack | 33647 | Medicine | A | 7/22/1992 | |
| MARVELON desogestrel / ethinylestradiol 28 tablets | 42894 | Medicine | A | 12/16/1992 | |
| DROSPIRENONE/ ETHINYLOESTRADIOL-GH TABLETS 3 mg/30 micrograms drospirenone/ethinylestradiol 3 mg/30 micrograms tablet blister pack | 180562 | Medicine | A | 1/20/2012 | |
| ISABELLE TABLETS 3 mg/30 micrograms drospirenone/ethinylestradiol 3 mg/30 micrograms tablet blister pack | 180561 | Medicine | A | 1/20/2012 | |
| LENEST 30 ED levonorgestrel/ ethinylestradiol 150 micrograms/30 micrograms tablet composite pack | 233113 | Medicine | A | 11/3/2015 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SEASONIQUE | teva canada limited | 02346176 | Tablet - Oral | 0.03 MG | 4/18/2011 |
| ORTHO-CEPT TABLETS (21 DAY) | 02042541 | Tablet - Oral | 0.03 MG | 12/31/1993 | |
| NIKKI | 02416492 | Tablet - Oral | 0.02 MG | N/A | |
| MARFEM 21 | novopharm limited | 02328828 | Tablet - Oral | 0.03 MG | N/A |
| TRI-LENA LO 21 | actavis pharma company | 02443457 | Tablet - Oral | 0.025 MG | N/A |
| TRI-CYCLEN LO (28 DAY) | 02258587 | Tablet - Oral | 0.025 MG | 1/27/2005 | |
| RECLIPSEN 21 | actavis pharma company | 02420813 | Tablet - Oral | 0.03 MG | 6/29/2014 |
| TRI-CIRA 28 | 02508095 | Tablet - Oral | 0.035 MG | 3/8/2021 | |
| TRI-CYCLEN TABLETS - 21-DAY | 02028700 | Tablet - Oral | 0.035 MG | 12/31/1993 | |
| ORTHO 7/7/7 TABLETS (28 DAY) | 00602965 | Tablet - Oral | 0.035 MG | 12/31/1983 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ANTIN 0,03 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 76087 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| AILEVA 0,1 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Cinfa S.A. | 82082 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CIRCLET 0,120 mg/0,015 mg CADA 24 HORAS, SISTEMA DE LIBERACION VAGINAL | Organon Salud S.L. | 73615 | SISTEMA DE LIBERACIÓN VAGINAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| MICROGYNON 0,15mg/0,03mg COMPRIMIDOS RECUBIERTOS | Bayer Plc | PL00010-0545 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| OEDIEN 2 MG/0,03 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratoires Bailleul S.A. | 81666 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| Melodene - 15 0,06mg/0,015mg comprimidos recubiertos con pelicula | BE212222 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| BEMASIVE 0,15 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | BE339412 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| LOETTE DIARIO 100/20 microgramos COMPRIMIDOS RECUBIERTOS CON PELICULA | Wyeth Farma S.A. | 66628 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| YASMIN DIARIO 3mg/0,03mg comprimidos recubiertos con pelicula | Bayer Ab | 00-2881 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| GYNOVIN 0,075 mg / 0,03 mg COMPRIMIDOS RECUBIERTOS | Bayer Hispania S.L. | 59044 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| 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 |
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| No UK EMC drug information found for this drug. | |||||
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