Last reviewed 2026-04-22 · How we verify

Levonorgestrel/Ethinyl Estradiol

Levonorgestrel/Ethinyl Estradiol is a Combined oral contraceptive Small molecule drug developed by Wyeth is now a wholly owned subsidiary of Pfizer. It is currently FDA-approved for Contraception (prevention of pregnancy), Regulation of menstrual cycle, Treatment of acne vulgaris.

This combination oral contraceptive suppresses ovulation by inhibiting the luteinizing hormone surge through progestin and estrogen feedback on the hypothalamic-pituitary axis.

This combination oral contraceptive suppresses ovulation by inhibiting the luteinizing hormone surge through progestin and estrogen feedback on the hypothalamic-pituitary axis. Used for Contraception (prevention of pregnancy), Regulation of menstrual cycle, Treatment of acne vulgaris.

At a glance

Mechanism of action

Levonorgestrel, a synthetic progestin, and ethinyl estradiol, a synthetic estrogen, work together to prevent pregnancy through multiple mechanisms: suppression of the LH surge needed for ovulation, thickening of cervical mucus to impede sperm transport, and alteration of the endometrium to prevent implantation. The progestin provides the primary contraceptive effect while the estrogen stabilizes the endometrium and regulates the menstrual cycle.

Approved indications

• Contraception (prevention of pregnancy)
• Regulation of menstrual cycle
• Treatment of acne vulgaris
• Treatment of polycystic ovary syndrome (PCOS) symptoms

Common side effects

• Nausea
• Headache
• Breast tenderness
• Breakthrough bleeding
• Mood changes
• Venous thromboembolism
• Hypertension

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.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Levonorgestrel/Ethinyl Estradiol CI brief — competitive landscape report
• Levonorgestrel/Ethinyl Estradiol updates RSS · CI watch RSS
• Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI

Frequently asked questions about Levonorgestrel/Ethinyl Estradiol

Related

• Drug class: All Combined oral contraceptive drugs
• Target: All drugs targeting Progesterone receptor, estrogen receptor alpha and beta
• Manufacturer: Wyeth is now a wholly owned subsidiary of Pfizer — full pipeline
• Therapeutic area: All drugs in Contraception / Gynecology
• Indication: Drugs for Contraception (prevention of pregnancy)
• Indication: Drugs for Regulation of menstrual cycle
• Indication: Drugs for Treatment of acne vulgaris

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing