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Levonorgestrel and ethinylestradiol
Levonorgestrel and ethinylestradiol is a combined oral contraceptive that prevents ovulation by suppressing gonadotropin hormones and altering cervical mucus and endometrial conditions.
Levonorgestrel and ethinylestradiol is a combined oral contraceptive that prevents ovulation by suppressing gonadotropin hormones and altering cervical mucus and endometrial conditions. Used for Contraception / prevention of pregnancy, Regulation of menstrual cycle.
At a glance
| Generic name | Levonorgestrel and ethinylestradiol |
|---|---|
| Sponsor | IVI Madrid |
| Drug class | Combined oral contraceptive |
| Target | Progesterone receptor (levonorgestrel); estrogen receptor (ethinylestradiol) |
| Modality | Small molecule |
| Therapeutic area | Contraception / Reproductive Health |
| Phase | FDA-approved |
Mechanism of action
Levonorgestrel is a synthetic progestin that inhibits the luteinizing hormone (LH) surge necessary for ovulation, while ethinylestradiol is a synthetic estrogen that suppresses follicle-stimulating hormone (FSH) to prevent follicle development. Together, these hormones create a contraceptive effect through multiple mechanisms: inhibition of ovulation, increased cervical mucus viscosity to impede sperm transport, and endometrial atrophy to prevent implantation.
Approved indications
- Contraception / prevention of pregnancy
- Regulation of menstrual cycle
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Mood changes
- Venous thromboembolism
Key clinical trials
- A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause (PHASE1)
- A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (PHASE1)
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding (NA)
- Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR (PHASE2)
- A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (PHASE1)
- A Study of Elenestinib in Healthy Adult Female Participants (PHASE1)
- A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (PHASE1)
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:
- Levonorgestrel and ethinylestradiol CI brief — competitive landscape report
- Levonorgestrel and ethinylestradiol updates RSS · CI watch RSS
- IVI Madrid portfolio CI