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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|---|---|---|---|---|---|
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NMPA Drug Approvals
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PPB Drug Approvals
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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 |
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