Antiandrogenic COC
ATC code: G03HB01 (Cyproterone and estrogen)
Cyproterone is a potent progestin with strong antiandrogenic activity: blocks androgen receptors and inhibits 5-alpha-reductase. Plus ethinylestradiol 35 µg. Lowers free testosterone by raising SHBG. Diane 35 has elevated VTE risk (1.5-2× 2nd-gen COCs); by 2013, indications are limited to severe acne and hirsutism unresponsive to other therapy.
Second line
Severe acne with hirsutism unresponsive to topical retinoids and systemic antibiotics. Per AEDV 2023 and 2013, Diane 35 is second-line after systemic retinoids (isotretinoin) in women who also need contraception. Use no longer than 3-6 months after symptom resolution. Switch to drospirenone- or dienogest-containing COCs if contraception is still needed.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Diane 35 is not first-line for regular contraception. By 2013, indications are limited to acne and hirsutism; contraception is a secondary effect. In women without hyperandrogenism, VTE risk outweighs benefit. If Diane 35 was prescribed «for contraception» with clear skin and a normal cycle, consider seeking a second opinion.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Boxed warning
EMA 2013: indications restricted to severe acne and hirsutism due to elevated VTE risk. EMA 2020: long-term cyproterone use linked to meningioma risk.
Contraindicated in pregnancy.
Contraindicated during lactation – cyproterone transfers to milk (RID about 0.2-1%), estrogen reduces milk supply, and cyproterone has antiandrogenic effect on male infants. Hale L4.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Cyproterone acetate + Ethinylestradiol is evaluated for the following indications with varying evidence strength: Acne and PCOS with hyperandrogenism (evidence tier B), Contraception (evidence tier D). See the full indication matrix with dosing and citations above on this page.
Common side effects of Cyproterone acetate + Ethinylestradiol (≥ 1 in 100): Nausea, Breast tenderness, Headache, Decreased libido, Depressive episodes. See the Safety section for uncommon and serious reactions.
FDA category X. Contraindicated in pregnancy.
Contraindicated during lactation – cyproterone transfers to milk (RID about 0.2-1%), estrogen reduces milk supply, and cyproterone has antiandrogenic effect on male infants. Hale L4.
Cyproterone acetate + Ethinylestradiol is contraindicated in: History/current VTE; Thrombophilia; Smoking after 35; Migraine with aura; Uncontrolled HTN. Full list in the Safety section.
EMA 2013: indications restricted to severe acne and hirsutism due to elevated VTE risk. EMA 2020: long-term cyproterone use linked to meningioma risk.