Diane-35^® (2mg cyproterone acetate and 0.035mg ethinyl estradiol)

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EFFICACY

• Improvements in seborrhea are generally seen after 2 to 3 months.
• Improvements to acne are generally seen after 3 to 4 months.
• Numerous studies have proven the efficacy of hormonal therapy in treating acne over 6 or more months of use.
• Many studies demonstrated the efficacy of Diane-35 in acne over the last 20 years: The Aydinlik trial that included 1161 patients followed for 3 years showed facial acne significantly improved or healed in 72%, 91% and 100% after 6, 12 and 36 months of treatment.
• In a comparative trial with Minovral (levonorgestrel 150ug/EE 30ug), Diane had a 70% reduction of acne after 6 cycles compared to 35% for the levonorgestrel preparation.
• Another study comparing Diane-35 and Marvelon (desogestrel 150ug/EE 30ug) over a period of 9 months found acne to improved by 81% with Diane-35 and 63% with Marvelon.
• Greenwood compared the reduction of lesion between Diane-35 and tetracycline. Results were 74% for Diane-35 and 68% for tetracycline.
• In the small number of women with severe hyperandrogenism and in whom progress is poor after 3 to 6 months of Diane-35® alone, additional cyproterone acetate of 12.5 to100 mg/day may be given on days 5-14 of the menstrual cycle. This is not commonly done for acne control.


• Side effects of these higher doses include:
• fatigue
• depression
• reduced libido
• weight gain
• breast tenderness
• worsening of the lipid profile.

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