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.
Background
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 |
|---|---|---|---|---|---|
2020/02/05 | Phase 2 | UNKNOWN | |||
2019/05/17 | Phase 4 | UNKNOWN | |||
2019/03/20 | Phase 1 | UNKNOWN | |||
2019/01/28 | Phase 4 | Completed | |||
2018/05/21 | Phase 4 | Terminated | |||
2017/10/04 | Phase 1 | Completed | |||
2017/04/24 | Phase 4 | Completed | Adana Numune Training and Research Hospital | ||
2017/01/31 | Early Phase 1 | UNKNOWN | |||
2016/01/12 | Phase 1 | Completed | |||
2015/06/02 | Not Applicable | Completed | Manuel Luque Ramírez |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | 68462-132 | ORAL | 0.02 mg in 1 1 | 6/22/2022 | |
| Direct_Rx | 72189-215 | ORAL | 20 ug in 1 1 | 10/6/2022 | |
| AvKARE | 42291-478 | VAGINAL | 0.015 mg in 1 d | 9/21/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-7280 | ORAL | 0.02 mg in 1 1 | 9/6/2017 | |
| Northstar Rx LLC | 16714-029 | VAGINAL | 0.015 mg in 1 d | 7/1/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1190 | TRANSDERMAL | 35 ug in 1 mg | 9/16/2023 | |
| Nivagen Pharmaceuticals, Inc. | 75834-130 | ORAL | 0.005 mg in 1 1 | 8/22/2022 | |
| Xiromed, LLC | 70700-313 | ORAL | 0.02 mg in 1 1 | 4/21/2025 | |
| Actavis Pharma, Inc. | 52544-295 | ORAL | 20 ug in 1 1 | 12/31/2021 | |
| Organon LLC | 78206-146 | VAGINAL | 0.015 mg in 1 d | 1/9/2023 |
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 |
|---|---|---|---|---|---|
| JASTINDA FILM COATED TABLETS 3MG/ 0.02MG | SIN14995P | TABLET, FILM COATED | 0.02 mg | 4/28/2016 | |
| BELARA film-coated tablet 0.03mg/2mg | SIN14870P | TABLET, FILM COATED | 0.030 mg | 10/14/2015 |
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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