Last reviewed · How we verify
Ethinylestradiol / Norethisterone
Ethinylestradiol and norethisterone work together as a combined oral contraceptive by suppressing ovulation through hormonal feedback on the hypothalamic-pituitary-ovarian axis.
Ethinylestradiol and norethisterone work together as a combined oral contraceptive by suppressing ovulation through hormonal feedback on the hypothalamic-pituitary-ovarian axis. Used for Contraception, Regulation of menstrual cycle, Treatment of menorrhagia.
At a glance
| Generic name | Ethinylestradiol / Norethisterone |
|---|---|
| Also known as | Loestrin 30, Galen Ltd, UK |
| Sponsor | University of Edinburgh |
| Drug class | Combined oral contraceptive |
| Target | Estrogen receptor and progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Reproductive Health |
| Phase | FDA-approved |
Mechanism of action
Ethinylestradiol is a synthetic estrogen that inhibits follicle-stimulating hormone (FSH) secretion, while norethisterone is a synthetic progestin that inhibits luteinizing hormone (LH) secretion and alters the endometrium. Together, they prevent the LH surge necessary for ovulation and create an unfavorable uterine environment for implantation.
Approved indications
- Contraception
- Regulation of menstrual cycle
- Treatment of menorrhagia
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Venous thromboembolism
- Hypertension
- Weight gain
Key clinical trials
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
- Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age (EARLY_PHASE1)
- Ovulation Incidence in Oral Contraceptive Users (PHASE3)
- Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive (PHASE1)
- International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
- Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers (PHASE3)
- Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ethinylestradiol / Norethisterone CI brief — competitive landscape report
- Ethinylestradiol / Norethisterone updates RSS · CI watch RSS
- University of Edinburgh portfolio CI