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Cyproterone + ethinylestradiol Pregnancy: Not indicated during pregnancy — pregnancy is an absolute contraindication and must be excluded before treatment is begun. If pregnancy occurs during treatment, further intake must be stopped. Animal studies show feminisation of male foetuses may occur if cyproterone acetate is given during the phase of embryogenesis at which differentiation of the external genitalia occurs; the possibility must be considered that administration after the 45th day of pregnancy could cause feminisation of male foetuses. Breast-feeding: use may reduce the volume of milk produced and change its composition, and minute amounts of the active substances are excreted in milk — these may affect the child particularly in the first 6 weeks post-partum; mothers who are breast-feeding should be advised not to take co-cyprindiol until the child is weaned.

Co-cyprindiol

Brand names: Dianette, Clairette

Co-cyprindiol is a combined preparation of cyproterone acetate (an anti-androgen) and ethinylestradiol used for moderately severe acne and androgen-dependent skin conditions in women.

Adult dose

Dose: Moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age — for acne, only after topical therapy or systemic antibiotic treatments have failed (§4.1): one tablet (cyproterone acetate 2000 microgram with ethinylestradiol 35 microgram) daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1). Each subsequent course is started after 7 tablet-free days have followed the preceding course.
Route: PO (oral)
Frequency: Once daily for 21 days, then 7 tablet-free days, repeated cyclically
Max: One tablet daily. Co-cyprindiol inhibits ovulation and thereby prevents conception, so an additional hormonal contraceptive must not be used alongside it — that would expose the patient to an excessive dose of hormones and is not necessary for effective contraception (§4.2; concomitant use with another hormonal contraceptive is a §4.3 contraindication).
Licensed indication (§4.1, verbatim): 'Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Co-cyprindiol should only be used after topical therapy or systemic antibiotic treatments have failed. Since Co-cyprindiol is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3).' || DURATION OF USE (§4.2): time to relief of symptoms is at least three months; the need to continue treatment should be evaluated periodically by the treating physician. || MISSED TABLET (§4.2): a single delayed tablet should be taken as soon as possible; if that is within 12 hours of the correct time, contraceptive protection is maintained. With longer delays additional contraception is needed — take only the most recently delayed tablet, omit earlier missed tablets, and use additional non-hormonal methods (except rhythm or temperature methods) for the next 7 days. If tablets were missed during the last 7 days of a pack, start the next pack with no break; a withdrawal bleed should not then be expected until the end of the second pack. || GASTRO-INTESTINAL UPSET (§4.2): vomiting or diarrhoea may reduce efficacy by preventing full absorption. Continue the current pack and use additional non-hormonal contraception during the upset and for 7 days afterwards, running packs together if those 7 days overrun the pack. || SWITCHING (§4.2): from a 21-day combined oral contraceptive, take the first Co-cyprindiol tablet on the first day immediately after the end of the previous course; from a combined every-day (28-tablet) pill, start the day after the last active tablet; from a progestogen-only pill, start on the first day of bleeding (even if a POP was taken that day) and discard the remaining POPs. No additional contraceptive precautions are required in any of these three cases. || POST-PARTUM / POST-ABORTUM (§4.2): may be started 21 days after a vaginal delivery provided the patient is fully ambulant and there are no puerperal complications, with additional contraceptive precautions for the first 7 days; since the first post-partum ovulation may precede the first bleeding, another method should be used between childbirth and the first course. After a first-trimester abortion it may be started immediately with no additional precautions. Lactation is contraindicated. || If bleeding fails to occur during the tablet-free interval, exclude pregnancy before starting the next pack. || Not for use in men (§4.3). || Co-cyprindiol does not protect against HIV infection (AIDS) or other sexually transmitted diseases (§4.4).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Concomitant use with another hormonal contraceptive
  • Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
  • Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack)
  • Presence or history of cerebrovascular accident
  • Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis — such as diabetes mellitus with vascular symptoms, severe hypertension, or severe dyslipoproteinaemia
  • Hereditary or acquired predisposition for venous or arterial thrombosis — such as activated protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
  • History of migraine with focal neurological symptoms
  • Presence or history of severe hepatic disease (e.g. active viral hepatitis, severe cirrhosis) as long as liver function values have not returned to normal
  • Presence or history of liver tumours (benign or malignant)
  • Current or history of breast cancer
  • Known or suspected pregnancy
  • Breast-feeding
  • Hypersensitivity to the active substances or to any of the excipients
  • Meningioma or history of meningioma
  • Concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir
  • Not for use in men

Side effects

  • Nausea and abdominal pain — common (the most commonly reported reactions occur in 1% or more of users)
  • Weight increased — common
  • Headache — common
  • Depressed mood and mood altered — common
  • Breast pain and breast tenderness — common
  • Thromboembolism — there is an increased risk of thromboembolism for all women who use co-cyprindiol; the incidence of VTE is 1.5 to 2 times higher than in users of levonorgestrel-containing combined oral contraceptives, and VTE can be fatal in 1-2% of cases (§4.4)
  • Vomiting, diarrhoea — uncommon
  • Migraine — uncommon; hypersensitivity — uncommon
  • Fluid retention — uncommon; weight decreased — uncommon
  • Libido decreased / libido increased
  • Breast hypertrophy, vaginal discharge, breast discharge — uncommon/rare
  • Rash, urticaria — uncommon; erythema nodosum, erythema multiforme — rare; chloasma
  • Contact lens intolerance
  • Reduced menstrual flow, spotting, breakthrough bleeding, missed withdrawal bleeding, post-pill amenorrhoea — post-marketing
  • Liver function disturbances; Crohn's disease and ulcerative colitis; exacerbation of chorea; exacerbation of hereditary and acquired angioedema; hypertriglyceridaemia — post-marketing
  • Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour), though a causal relationship has not been established
  • NOTE: the SPC adverse-reaction table was truncated in this source capture — this list is not complete; consult the SPC

Monitoring

  • Before starting and at regular intervals thereafter (§4.4): personal and family medical history, and physical examination guided by that history and by §4.3/§4.4 — including measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology
  • Exclude the likelihood of pregnancy before starting treatment; investigate undiagnosed vaginal bleeding that is suspicious for underlying conditions (§4.4)
  • Mood and depressive symptoms (§4.4): depressed mood and depression are well-known undesirable effects of hormonal contraceptive use, and depression is a well-known risk factor for suicidal behaviour and suicide — advise women to contact their physician about mood changes and depressive symptoms, including shortly after initiating treatment. Patients with a history of depression should be monitored during treatment
  • Response and duration (§4.2/§4.4): time to relief of symptoms is at least three months; the need to continue treatment should be evaluated periodically by the treating physician
  • Meningioma (§4.4): if a patient is diagnosed with meningioma, any cyproterone-containing treatment, including co-cyprindiol, must be stopped as a precautionary measure
  • Stop immediately (§4.4) for: first occurrence or exacerbation of migrainous headaches or unusually frequent/severe headaches; sudden disturbance of vision or hearing or other perceptual disorder; first signs of thrombosis or blood clots (unusual leg pain or swelling, stabbing pain on breathing or coughing, chest pain or tightness); onset of jaundice, hepatitis or generalised itching; significant rise in blood pressure; onset of severe depression; severe upper abdominal pain or liver enlargement; pregnancy
  • Stop 6 weeks before elective major surgery (e.g. abdominal, orthopaedic), any leg surgery, medical treatment for varicose veins, or prolonged immobilisation — do not restart until 2 weeks after full ambulation; in emergency surgery thrombotic prophylaxis is usually indicated (§4.4)

Clinical monograph

How it works

Cyproterone acetate blocks androgen receptors and reduces sebum production, while the combination suppresses ovarian androgen output and provides cycle control.

Prescribing in practice

  • It carries a higher risk of venous thromboembolism than some combined oral contraceptives, so it should not be used solely as a contraceptive and treatment should be reviewed and usually stopped once the skin condition has responded.
  • It is contraindicated where combined hormonal contraceptives are contraindicated, including a history of venous or arterial thromboembolism and certain migraine with aura.
  • It should not be used in combination with another hormonal contraceptive because of the additive thrombotic risk.

Monitoring

Assess venous and arterial thromboembolism risk factors, blood pressure, and treatment response before and during use, and review the need to continue periodically.

Counselling the patient

  • Seek urgent medical advice for symptoms of a clot such as a swollen, painful calf, chest pain, or sudden breathlessness.
  • This is taken for your skin condition; it also acts as a contraceptive but should not be used for contraception alone.
  • Treatment is usually stopped some months after the skin condition has cleared.

Evidence & guidelines

The MHRA advises that co-cyprindiol carries an increased thromboembolism risk and should be used for defined dermatological indications rather than as a routine contraceptive.

Reference: MHRA Drug Safety Update; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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