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 |
|---|---|---|---|---|---|
2015/03/27 | Not Applicable | Completed | |||
2015/01/28 | N/A | Completed | |||
2014/03/18 | Phase 3 | Completed | |||
2014/01/06 | Phase 4 | UNKNOWN | Tyumen State Medical Academy | ||
2013/03/06 | Phase 4 | Withdrawn | Istanbul Training and Research Hospital | ||
2012/12/11 | Phase 1 | Completed | |||
2012/08/03 | Phase 3 | Terminated | |||
2012/05/22 | Phase 1 | UNKNOWN | |||
2012/04/04 | Phase 1 | Completed | |||
2011/12/26 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | 0378-7274 | ORAL | 0.03 mg in 1 1 | 2/19/2018 | |
| Zydus Lifesciences Limited | 70771-1777 | TRANSDERMAL | 35 ug in 1 mg | 9/16/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-3340 | TRANSDERMAL | 35 ug in 1 d | 2/4/2021 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-504 | ORAL | 0.03 mg in 1 1 | 6/21/2022 | |
| A-S Medication Solutions | 50090-5959 | VAGINAL | 0.015 mg in 1 d | 1/13/2023 | |
| TherapeuticsMD, Inc. | 50261-313 | VAGINAL | 17.4 mg in 1 1 | 1/13/2021 | |
| Lupin Pharmaceuticals, Inc. | 68180-827 | ORAL | 0.0025 mg in 1 1 | 12/13/2023 | |
| Teva Women's Health LLC | 51285-131 | ORAL | 20 ug in 1 1 | 8/30/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-828 | ORAL | 0.005 mg in 1 1 | 12/13/2023 | |
| Physicians Total Care, Inc. | 54868-4679 | ORAL | 5 ug in 1 1 | 8/31/2010 |
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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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DEMULEN 30 (28 DAY PACK) | 00471526 | Tablet - Oral | 30 MCG | 12/31/1979 | |
| DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 21 | Mylan Pharmaceuticals ULC | 02424452 | Tablet - Oral | 0.03 MG | N/A |
| OVRAL 21 | 02043033 | Tablet - Oral | 50 MCG | 9/20/1996 | |
| MIN-OVRAL 28 TAB | wyeth ltd. | 00782440 | Tablet - Oral | .03 MG | 12/31/1989 |
| HALOETTE | searchlight pharma inc | 02520028 | Ring (Slow-Release) - Vaginal | 2.7 MG | 9/29/2021 |
| SELECT 1/35 (21-DAY) | 02197502 | Tablet - Oral | 0.035 MG | 5/1/1997 | |
| RECLIPSEN 28 | actavis pharma company | 02417464 | Tablet - Oral | 0.03 MG | 6/29/2014 |
| AUDRINA 21 | 02532174 | Tablet - Oral | 20 MCG | 6/9/2023 | |
| ORTHO 7/7/7 TABLETS (21 DAY) | 00602957 | Tablet - Oral | 0.035 MG | 12/31/1983 | |
| SYNPHASIC 21 TABLETS | 02187108 | Tablet - Oral | 0.035 MG | 8/14/1996 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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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 |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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