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Ethinylestradiol + Norgestimate

COC with norgestimate

ATC code: G03AA11(Norgestimate and estrogen)

Updated · Methodology

Indications

B

Acne and PCOS with hyperandrogenism

Second line

Moderate acne in women who also need contraception. Per AEDV 2023, COCs with antiandrogenic progestins (norgestimate, dienogest, drospirenone) are second-line after topical retinoids and systemic antibiotics. Effect by 3–6 months. For acne without contraceptive need, systemic retinoids or antibiotics, not COCs.

Sources

  1. AEMPS: Ficha técnica de Etinilestradiol + Levonorgestrel (2024)
  2. ESHRE: International evidence-based guideline for the assessment and management of polycystic ovary syndrome (2023)

ICD-10: L70.0 · ICD-11: ED80

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Norgestimate is a progestin with minimal androgenic activity, metabolized to levonorgestrel and norelgestromin. Ethinylestradiol + norgestimate suppresses ovulation. Per , norgestimate COC is also approved for moderate acne in women ≥15 who need contraception.

Safety

Contraindications

  • VTE
  • Thrombophilia
  • Smoking after 35
  • Migraine with aura
  • HTN
  • Breast cancer
  • First 6 weeks postpartum
  • Pregnancy

Serious adverse effects

  • VTE
  • Stroke
  • HTN

Common adverse effects

  • Nausea
  • Breast tenderness
  • Spotting

Pregnancy: can you take Ethinylestradiol + Norgestimate?

Discontinue if pregnant.

Breastfeeding: can you take Ethinylestradiol + Norgestimate?

Hale L3 · Probably compatible, limited data

Estrogen reduces milk. WHO MEC first 6 weeks – category 4, then 2. Norgestimate metabolizes to levonorgestrel, RID about 1%, Hale L3.

RID, infant dose via milk
1%
Maternal half-life
22.0 h
Maternal peak time
2 h
Peak milk concentration
0 mg/L
Milk-to-plasma ratio
0.3
Calculate RIDSafe feeding windowFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

21 + 7 days. Acne effect by 3–6 months. If no improvement at 6 months, review strategy.

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Frequently asked

What is Ethinylestradiol + Norgestimate used for?

Ethinylestradiol + Norgestimate is evaluated for the following indications with varying evidence strength: Contraception (evidence tier A), Acne and PCOS with hyperandrogenism (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Ethinylestradiol + Norgestimate?

Common side effects of Ethinylestradiol + Norgestimate (≥ 1 in 100): Nausea, Breast tenderness, Spotting. See the Safety section for uncommon and serious reactions.

Is Ethinylestradiol + Norgestimate safe during pregnancy?

Discontinue if pregnant.

Is Ethinylestradiol + Norgestimate compatible with breastfeeding?

Estrogen reduces milk. WHO MEC first 6 weeks – category 4, then 2. Norgestimate metabolizes to levonorgestrel, RID about 1%, Hale L3.

Who should not take Ethinylestradiol + Norgestimate?

Ethinylestradiol + Norgestimate is contraindicated in: VTE; Thrombophilia; Smoking after 35; Migraine with aura; HTN. Full list in the Safety section.

Other drugs in this group

Etonogestrel (implant), Follitropin alfa, Levonorgestrel, Medroxyprogesterone acetate depot, Mifepristone, Tibolone, Desogestrel, Estradiol valerate + Dienogest