Diane

Diane-35 contains two active ingredients — cyproterone acetate (2 mg) and ethinylestradiol (35 mcg) — and is manufactured by Bayer. Also known by the generic name co-cyprindiol, this combination medication was first authorized in Germany in 1985 and has since become available across Europe, Israel, and many other countries. Diane-35 is primarily indicated for treating moderate to severe acne related to androgen sensitivity and hirsutism (excessive hair growth) in women of reproductive age, and it also functions as an effective oral contraceptive.

How Diane-35 Works

Cyproterone acetate is a progestogen with strong anti-androgenic properties. It works by blocking androgen receptors in the body, which reduces the effects of male hormones (androgens) on the skin and hair follicles. It also suppresses androgen production through a negative feedback effect on the hypothalamic-pituitary-ovarian axis.

The second ingredient, ethinylestradiol, is a synthetic form of estrogen that works together with cyproterone to regulate the menstrual cycle and prevent ovulation. This combination provides contraceptive protection through three mechanisms: it prevents the release of eggs from the ovaries, thickens cervical mucus to block sperm passage, and alters the uterine lining to reduce the chance of implantation. Patients interested in learning about other hormonal treatment options can explore our hormone and bone health medications section.

Clinical Effectiveness for Acne and Hirsutism

Clinical studies reviewed by the European Medicines Agency (EMA) have confirmed that Diane-35 is effective in treating moderate to severe acne associated with androgen sensitivity. Improvement in acne symptoms typically begins after 3 to 4 cycles of treatment, with more pronounced results seen with longer use. For hirsutism, the anti-androgenic effects of cyproterone acetate help reduce unwanted facial and body hair growth over several months of consistent use.

According to the EMA’s assessment, Diane-35 showed superior efficacy compared to levonorgestrel-containing oral contraceptives in treating these androgen-dependent conditions. The medication is also used in managing symptoms of polycystic ovary syndrome (PCOS), including hormonal imbalances, irregular periods, and hyperandrogenic skin symptoms.

Dosing Guidelines

Diane-35 is taken orally once daily for 21 consecutive days, followed by a 7-day tablet-free interval during which a withdrawal bleed typically occurs. Each blister pack contains 21 tablets, and the next pack should be started after the 7-day break regardless of whether bleeding has stopped. Tablets should be taken at approximately the same time each day, preferably with a small amount of liquid. If a tablet is missed by less than 12 hours, it should be taken as soon as remembered and the next tablet taken at the usual time. If more than 12 hours have passed, contraceptive protection may be reduced and additional precautions should be considered for the next 7 days.

Treatment with Diane-35 should be discontinued once the androgen-dependent skin condition has resolved, which usually takes several months. The medication should not be used solely as a contraceptive — women who need only birth control should be prescribed a standard oral contraceptive instead. Women who also need treatment for conditions like androgen-related symptoms may discuss this option with their prescriber.

Who Should Not Take Diane-35

Diane-35 is contraindicated in women with a history of venous or arterial thromboembolism (blood clots), including deep vein thrombosis, pulmonary embolism, stroke, or heart attack. It should also not be used by women with known risk factors for blood clots such as prolonged immobilization, major surgery, severe obesity, or certain inherited clotting disorders.

Other contraindications include severe liver disease or a history of liver tumors, known or suspected hormone-dependent cancers, unexplained vaginal bleeding, and pregnancy. Women who smoke — especially those over the age of 35 — face a significantly increased risk of cardiovascular side effects. The medication should not be taken together with other hormonal contraceptives. Patients managing heart health conditions should consult their doctor before starting any hormonal therapy.

Comparing Diane-35 to Other Hormonal Options

Unlike standard combined oral contraceptives, Diane-35 contains cyproterone acetate which has specific anti-androgenic activity that most progestins lack. This makes it particularly suited for women whose acne or hirsutism hasn’t responded to topical treatments or antibiotics. Women who are using hormonal therapy for other gynecological conditions may also consider medications like Depo-Provera (medroxyprogesterone) for contraception, or Climara for estrogen-related hormone management, depending on their clinical needs. Our blog post on hormonal health topics provides additional background on how hormones affect the body.

Storage and Handling

Store Diane-35 tablets at room temperature below 30°C (86°F) in the original blister packaging. Keep the medication away from moisture and direct sunlight, and store it out of reach of others.

Buying Diane-35 Online

If you’re looking to buy Diane online at an affordable price, licensed international pharmacies can help you save on prescription costs compared to local pricing. At our online pharmacy, Diane-35 is available as the original Bayer-manufactured product with 21 tablets per pack. Orders over $150 qualify for free shipping, and all medications are sourced from licensed dispensaries.