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Also known as Levonorgestrel
levonorgestrel/ethinyl estradiol · 6 trials · 5 indications
| Name | Type | Description |
|---|---|---|
| Levonorgestrel/Ethinyl Estradiol | DRUG | - |
| Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg | DRUG | - |
| Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg | DRUG | - |
| Levonorgestrel | DRUG | - |
| Ethinyl Estradiol | DRUG | - |
Inclusion Criteria: * Generally healthy, women aged 18 to 49 years. * History of severe PMS symptoms over the last year, as determined by the investigator. * Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. Exclusion Criteria: * Major depressive disorder requiring ant...
Levonorgestrel/ethinyl estradiol is a small molecule combination developed by Pfizer for contraception and related endocrine conditions. It pairs levonorgestrel with ethinyl estradiol and has been studied in oral contraception, ovulation, premenstrual syndrome, and menstruation disturbances. It is investigational and remains in clinical development.
Levonorgestrel/ethinyl estradiol targets the progesterone receptor (PGR) as an agonist. The levonorgestrel component acts on PGR, while ethinyl estradiol is an estrogen. This receptor activity underlies its use in contraception and menstrual cycle related conditions.
Pfizer, Inc. (ticker PFE) is the developer of levonorgestrel/ethinyl estradiol. Pfizer has sponsored the clinical trials evaluating this combination in contraception and related indications.
Levonorgestrel/ethinyl estradiol is in Phase 3 development. It is investigational and has not been approved by the FDA for the studied indications. The clinical program includes completed Phase 2 and Phase 3 trials.
Levonorgestrel/ethinyl estradiol has been studied in completed trials including NCT00254189 (Phase 2, ovulation), NCT00248963 (Phase 3, oral contraception), NCT00245921 (Phase 3, contraception), and NCT00195559 (Phase 3, premenstrual syndrome and menstruation disturbances). All are completed.