Diane 35

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How Diane 35 Works

Diane 35 combines two mechanisms. Cyproterone acetate is a potent anti-androgen that competes with testosterone and dihydrotestosterone (DHT) at the androgen receptor in skin and hair follicles, reducing sebum production and slowing terminal hair growth on androgen-dependent areas. Ethinylestradiol is a synthetic estrogen that suppresses ovulation, increases sex hormone-binding globulin (SHBG) — which lowers circulating free testosterone — and provides cycle control.

The combination provides contraceptive efficacy comparable to other COCs (Pearl Index ~0.7 with perfect use, ~7 with typical use), while the anti-androgen action improves moderate-to-severe acne in 70–80% of women within 3–6 months and reduces hirsutism scores in 60–70% over 6–9 months.

Indicaties

Diane 35 is licensed for treatment of moderate-to-severe acne related to androgen sensitivity (with or without seborrhoea) and/or for mild hirsutism in women of reproductive age, where topical treatment or oral antibiotics have not adequately controlled the condition. Contraception is automatically provided and the product should not be used in combination with another hormonal contraceptive (this would unnecessarily multiply the VTE risk).

It is sometimes prescribed off-label for polycystic ovary syndrome (PCOS) presenting with acne or hirsutism, and as anti-androgen therapy in transgender women under specialist supervision.

Dosering

Long-term continuous use beyond 24–36 months without symptom benefit is generally not recommended given the cumulative VTE exposure; alternative anti-androgen strategies (spironolactone, isotretinoin, finasteride for hirsutism) should be considered.

Contra-indicaties

• Personal or family history of venous or arterial thromboembolism (DVT, PE, MI, stroke) or known thrombogenic mutations (factor V Leiden, prothrombin G20210A, protein C/S/antithrombin deficiency, antiphospholipid antibodies)
• Smoking after age 35
• Severe hypertension (≥160/100 mmHg) or vascular disease
• Migraine with aura at any age, or migraine without aura after age 35
• Diabetes with vascular complications
• Active or past liver disease, liver tumours, severely impaired liver function
• Pregnancy or suspected pregnancy
• Breast cancer (current or past), undiagnosed vaginal bleeding
• Major surgery with prolonged immobilisation, prolonged immobilisation for any reason
• Concurrent use with another hormonal contraceptive

Bijwerkingen

Common (1–10%): nausea, breast tenderness, mood changes, headache, breakthrough bleeding (first 3 cycles), reduced libido (especially with cyproterone), weight changes, fluid retention.

Minder vaak: melasma (chloasma), depression, decreased glucose tolerance, hypertension.

Ernstig (zeldzaam): venous thromboembolism (DVT/PE — see red box above), arterial thromboembolism (stroke, MI), benign hepatic adenoma, exacerbation of systemic lupus erythematosus, exacerbation of cholelithiasis. Severe hypersensitivity is very rare.

Geneesmiddelinteracties

Hepatic enzyme inducers reduce contraceptive efficacy and may worsen acne control: rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate >200 mg/day, modafinil, St John’s wort, efavirenz, nevirapine, ritonavir-boosted regimens. Use barrier method during course and for 28 days after, or switch to a non-hormonal method.

Lamotrigine levels are reduced by ethinylestradiol (may increase seizures); coordinate dose adjustment with neurology. Cyproterone fraction may slightly increase ciclosporin levels.

Pregnancy & Breastfeeding

Absolute contraindication in pregnancy. If pregnancy is suspected, stop immediately and confirm with a test. Cyproterone acetate has anti-androgen activity that could feminise a male fetus during weeks 8–12 of gestation. Discontinue at least 1 cycle before planned conception.

Not recommended during breastfeeding; small amounts pass into breast milk and may reduce milk volume. If contraception is needed during lactation, use a progesterone-only pill.

Opslag

Store below 30 °C in original blister packaging. Protect from light.

Veelgestelde vragen

Is Diane 35 a regular contraceptive pill?

It provides reliable contraception (Pearl Index ~0.7) but it is licensed specifically for acne/hirsutism in women, not first-line contraception, because the cyproterone fraction approximately doubles VTE risk vs low-dose levonorgestrel COCs. Once acne or hirsutism is controlled, switching to a lower-VTE-risk COC is reasonable.

How long until acne improves?

Most women see meaningful acne improvement by cycle 3–4 and substantial improvement by cycle 6. Hirsutism takes longer — 6–9 months for visible reduction in terminal hair density. If no benefit is seen at 6 months, discontinuation should be considered.

Can I take Diane 35 long-term?

The cumulative VTE exposure rises with duration; continuous use beyond 24–36 months without ongoing acne/hirsutism control benefit is generally discouraged. Alternative anti-androgen strategies (spironolactone, oral isotretinoin for severe acne, finasteride for hirsutism) reduce hormonal exposure.

Diane 35 vs Yasmin (drospirenone) for acne?

Both reduce acne via anti-androgen activity. Drospirenone is a milder anti-androgen than cyproterone but Yasmin carries a slightly lower VTE risk (~7 vs ~9–15 per 10,000 woman-years). Yasmin is reasonable when acne is mild-moderate; Diane 35 is preferred when acne is severe or has not responded to other COCs.

Will Diane 35 reduce my libido?

The cyproterone fraction is a potent anti-androgen and can reduce libido; this is a more common side effect than with non-anti-androgen COCs. The effect is usually reversible on stopping but may persist for some weeks afterward.

Does Diane 35 help with PCOS?

Yes — it is widely used off-label for PCOS where acne, hirsutism, or oligomenorrhoea are presenting symptoms. The combination addresses the androgen-driven dermatological signs while providing cycle control and contraception. Metformin or weight management may be added depending on metabolic profile.

Can I use Diane 35 if I am over 35?

Only if you do not smoke and have no vascular risk factors (hypertension, diabetes, dyslipidaemia, obesity, migraine with aura). The age 35+ smoker exclusion is absolute. Many specialists prefer to stop COCs altogether at age 50.

How is Diane 35 different from spironolactone for acne?

Spironolactone is an oral anti-androgen often used for adult-onset hormonal acne; it does not provide contraception (and is teratogenic, so requires reliable contraception alongside). Diane 35 combines anti-androgen activity with contraception in a single tablet. Some clinicians use both together for severe hirsutism.

What if I miss a pill?

Less than 12 hours late: take immediately, no precautions needed. More than 12 hours late: take immediately, take the next pill on time, and use barrier protection for the next 7 days. If 3+ pills are missed in week 1 and intercourse occurred, consider emergency contraception.

Will it cause weight gain?

Most modern COCs cause minimal weight change. Some women notice fluid retention (1–2 kg) early in treatment that often resolves. The cyproterone fraction has mild glucocorticoid activity that may contribute to mild fluid retention.

Other Contraceptive & Hormonal Medications

• Yasmin — drospirenone 3 mg + ethinylestradiol 0.03 mg (Bayer) — milder anti-androgen, lower VTE risk than Diane 35
• Loette — levonorgestrel 0.1 mg + ethinylestradiol 0.02 mg (Wyeth) — lowest VTE risk of any COC, first-line for routine contraception
• Femilon — desogestrel 0.15 mg + ethinylestradiol 0.02 mg — third-generation COC
• Cerazette — desogestrel 75 mcg progesterone-only pill — preferred during breastfeeding or where estrogen is contraindicated
• Finpecia — finasteride 1 mg — alternative anti-androgen for hirsutism (off-label in women, specialist supervision)

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