From the Guidelines
DIANE-35 TAB is primarily used for contraception and treating androgen-dependent conditions in women, such as severe acne and excessive hair growth (hirsutism), due to its combination of cyproterone acetate (2 mg) and ethinylestradiol (35 mcg). The standard regimen is to take one tablet daily for 21 consecutive days, followed by a 7-day break, during which a withdrawal bleed typically occurs. Start the next pack after the 7-day break, regardless of whether bleeding has stopped. For acne treatment, improvement is usually seen after about 3 months of use, but it may take up to 6 months for full effect, as noted in studies such as 1. Continue use as directed by your healthcare provider, typically for several cycles even after acne improves. DIANE-35 should not be used solely for contraception due to its higher risk profile compared to standard birth control pills. Important precautions: DIANE-35 is contraindicated in smokers over 35, those with a history of blood clots, certain types of migraines, liver disease, or hormone-sensitive cancers, as these conditions can increase the risk of adverse effects, as discussed in 1. It may increase the risk of blood clots, especially in the first year of use. Regular follow-ups with a healthcare provider are essential. The medication works by suppressing ovulation and altering cervical mucus, while the anti-androgenic effect helps improve acne and hirsutism. Some studies, like 1, have explored the use of cyproterone acetate in combination with other medications for treating conditions such as polycystic ovary syndrome (PCOS), highlighting its potential benefits in managing androgen-dependent symptoms. However, the primary use of DIANE-35 remains focused on its contraceptive and anti-androgenic properties for treating conditions like acne and hirsutism in women. Given the potential risks and benefits, it is crucial to use DIANE-35 under the guidance of a healthcare provider, especially considering its implications on morbidity, mortality, and quality of life. Key points to consider include:
- Contraindications such as smoking over 35, history of blood clots, and certain medical conditions
- Potential for increased risk of blood clots
- Importance of regular follow-ups with a healthcare provider
- Benefits in treating androgen-dependent conditions like acne and hirsutism
- Standard regimen and expected outcomes for acne treatment.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Usage of Diane-35 Tablets
The usage of Diane-35 (cyproterone acetate and ethinyl estradiol) tablets is primarily for the treatment of various conditions related to androgenization in women, including:
- Hirsutism: Diane-35 has been shown to be effective in reducing hirsutism scores and improving symptoms of excessive hair growth in women 2, 3.
- Acne: The tablets have been found to significantly improve or heal acne and seborrhea in women with mild to moderate androgenization 4.
- Polycystic ovarian syndrome (PCOS): Diane-35 has been used to treat women with PCOS, resulting in significant reductions in ovarian volume, stromal density, and follicle number and size, as well as improvements in hormonal parameters and hirsutism scores 3.
- Contraception: Although not its primary indication, Diane-35 is sometimes used as an oral contraceptive, despite concerns about its safety and efficacy compared to other contraceptive options 5, 6.
Key Findings
- Diane-35 has been found to be effective in reducing androgenization symptoms, including hirsutism and acne, in women with various conditions 2, 4, 3.
- The tablets have been shown to improve hormonal parameters, including reductions in serum testosterone and androstenedione levels, and increases in serum sex hormone-binding globulin (SHBG) levels 3.
- However, concerns have been raised about the safety of Diane-35, particularly with regards to the risk of venous thrombosis and other adverse effects 5, 6.