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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/02 | Not Applicable | Completed | |||
2024/05/02 | Not Applicable | Completed | |||
2024/03/22 | Phase 4 | Completed | |||
2023/11/24 | Phase 3 | Completed | |||
2023/11/15 | N/A | Active, not recruiting | |||
2023/09/15 | Phase 1 | Completed | |||
2023/07/07 | Phase 1 | Terminated | |||
2023/01/31 | Phase 1 | Completed | Janssen Pharmaceutica N.V., Belgium | ||
2021/07/22 | Phase 1 | Completed | |||
2021/04/05 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0555-9027 | ORAL | 30 ug in 1 1 | 8/14/2023 | |
| Agile Therapeutics, Inc. | 71671-100 | TRANSDERMAL | 2.30 mg in 1 1 | 9/11/2020 | |
| Teva Pharmaceuticals USA, Inc. | 0555-9025 | ORAL | 20 ug in 1 1 | 8/14/2023 | |
| A-S Medication Solutions | 50090-5611 | VAGINAL | 0.015 mg in 1 d | 1/9/2023 | |
| Bryant Ranch Prepack | 72162-2220 | TRANSDERMAL | 35 ug in 1 d | 1/5/2024 | |
| A-S Medication Solutions | 50090-1008 | VAGINAL | 0.015 mg in 1 d | 1/24/2020 | |
| Physicians Total Care, Inc. | 54868-4832 | VAGINAL | 2.7 mg in 1 1 | 2/9/2012 | |
| Teva Pharmaceuticals, Inc. | 0480-3472 | ORAL | 20 ug in 1 1 | 3/6/2023 | |
| Prasco Laboratories | 66993-605 | VAGINAL | 0.015 mg in 1 d | 1/13/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3122 | ORAL | 5 ug in 1 1 | 2/27/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/22/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GVEZA FILM COATED TABLETS 3MG/ 0.03MG | SIN14996P | TABLET, FILM COATED | 0.03 mg | 4/28/2016 | |
| MICROGYNON 30 TABLET | SIN04834P | TABLET, SUGAR COATED | 0.03 mg | 6/26/1990 | |
| YASMIN TABLET | SIN12334P | TABLET, FILM COATED | 0.03 mg | 6/25/2003 | |
| LIZA FILM-COATED TABLETS 3MG/0.03MG | SIN14894P | TABLET, FILM COATED | 0.03mg | 11/13/2015 | |
| ESTELLE-35 TABLET | SIN12117P | TABLET, FILM COATED | 0.035 mg | 10/31/2002 | |
| ESTELLE-35ED TABLET | SIN11974P | TABLET, FILM COATED | 0.035 mg | 6/4/2002 | |
| EVRA TRANSDERMAL PATCH (6 mg/600 mcg) | SIN12423P | PATCH | 600 mcg/patch | 9/17/2003 | |
| DIANE-35 TABLET | SIN04784P | TABLET, SUGAR COATED | 0.035 mg | 6/11/1990 | |
| MERCILON TABLET | SIN06136P | TABLET | 0.02 mg | 6/19/1991 | |
| DROSPERA FILM-COATED TABLETS 3 MG/0.02 MG | SIN14855P | TABLET, FILM COATED | 0.02mg | 9/22/2015 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HARMONET TAB | N/A | N/A | N/A | 2/19/1999 |