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 |
|---|---|---|---|---|---|
2007/10/26 | Phase 1 | Completed | |||
2007/07/20 | Phase 1 | Completed | |||
2006/11/01 | Phase 2 | Completed | |||
2006/08/22 | Phase 3 | Completed | |||
2006/04/17 | Phase 2 | UNKNOWN | |||
2005/11/15 | Phase 2 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2005/09/19 | Phase 3 | Completed | |||
2005/09/16 | Phase 3 | Completed | |||
2005/07/06 | Phase 3 | Withdrawn | |||
2005/07/06 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | 68462-637 | ORAL | 20 ug in 1 1 | 5/19/2022 |
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 |
|---|---|---|---|---|---|
| VALETTE ethinyloestradiol / dienogest tablet blister pack | 122788 | Medicine | A | 3/2/2006 | |
| MICRONELLE 20 ED levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet blister pack | 211154 | Medicine | A | 1/31/2014 | |
| ELEANOR 150/30 ED levonorgestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack | 205579 | Medicine | A | 2/3/2014 | |
| HEIDI-35 ED tablet blister pack | 422046 | Medicine | A | 1/3/2024 | |
| MONOFEME levonorgestrel and ethinylestradiol tablet blister pack | 296399 | Medicine | A | 1/23/2018 | |
| LENEST 20 ED levonorgestrel/ethinylestradiol 100 microgram/20 microgram tablet blister composite pack | 219146 | Medicine | A | 11/21/2014 | |
| EVELYN 150/30 ED levonorgestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack | 205575 | Medicine | A | 2/3/2014 | |
| JENE-35 ED tablet blister pack | 144128 | Medicine | A | 5/15/2008 | |
| FEMME-TAB ED 30/150 150mcg ethinylestradiol 30mcg film-coated tablet blister pack | 170388 | Medicine | A | 1/10/2012 | |
| MINULET tablet | 296803 | Medicine | A | 1/23/2018 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MILEY 21 | ambicare pharmaceuticals inc. | 02556553 | Tablet - Oral | 0.03 MG | N/A |
| ESTINYL TAB 0.05MG | schering-plough canada inc | 00028223 | Tablet - Oral | .05 MG / TAB | 12/31/1951 |
| TRIPHASIL 21 TAB | wyeth ltd. | 00782416 | Tablet - Oral | 30 MCG / TAB | 12/31/1989 |
| TRIPHASIL 21 TAB | wyeth ltd. | 00782416 | Tablet - Oral | 30 MCG | 12/31/1989 |
| TRIPHASIL 21 TAB | wyeth ltd. | 00782416 | Tablet - Oral | 40 MCG | 12/31/1989 |
| BREVICON 1/35 TABLETS (28-DAY PACK) | 02189062 | Tablet - Oral | 0.035 MG | 9/16/1996 | |
| CENTRISA 21 | 02411199 | Tablet - Oral | 0.035 MG | N/A | |
| CYCLEN TABLETS (28 DAY) | 01992872 | Tablet - Oral | 0.035 MG | 12/31/1992 | |
| SYNPHASIC 21 TABLETS | syntex inc. | 00620947 | Tablet - Oral | .035 MG / TAB | 12/31/1986 |
| SEASONIQUE | teva canada limited | 02346176 | Tablet - Oral | 0.01 MG | 4/18/2011 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AILYN DIARIO 2 MG/0,03 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Exeltis Healthcare S.L. | 77181 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| HARMONET 0,075 MG/0,02 MG COMPRIMIDOS RECUBIERTOS | Wyeth Farma S.A. | 61975 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| YASMIN 0,03mg/3mg comprimidos recubiertos con pelicula | Bayer Portugal Lda. | 3339181IP1 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| GESDINE 0,075 MG/0,02 MG COMPRIMIDOS EFG | Exeltis Healthcare S.L. | 80164 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| MELIANE COMPRIMIDOS RECUBIERTOS | 298 IS 187 F3 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MINULET 0,075 MG/0,03 MG COMPRIMIDOS RECUBIERTOS | Pfizer B.V. | RVG 12575IP | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ETINILESTRADIOL/DROSPIRENONA STADA 0,03 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 76057 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ANTINELLE 0,02 mg/3 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 76089 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MELIANE 0,075 mg / 0,02 mg COMPRIMIDOS RECUBIERTOS | Bayer Hispania S.L. | 61973 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| MITHRARING 0,120 MG/0,015 MG CADA 24 HORAS SISTEMA DE LIBERACION VAGINAL EFG | Novalon S.A. | 84449 | SISTEMA DE LIBERACIÓN VAGINAL | 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 |
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| 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 |
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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 |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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