Clinical Experience

  • Diane-35® (2mg cyproterone acetate and 0.035mg ethinyl estradiol) is approved for use in Canada to treat women with severe acne who are unresponsive to other available treatments and who have associated symptoms of androgenization, such as seborrhea and mild hirsutism. In addition to treating acne, Diane-35® also provides reliable contraception.
  • The drug is well tolerated. Any adverse effects are mild to moderate in intensity and are typical of those associated with oral contraceptives.
  • Diane-35 is the only estrogen/progestogen combination in which the progestin component is an antiandrogen and a derivative from 17-hydroxyprogesterone while others derive from 19-nortestosterone.
  • Diane-35® is considered the treatment of choice for women with acne (that appears after adolescence). It is currently used by more than 3 million women in more than 100 countries.


  • Used to treat women with severe* acne and its associated symptoms of androgenization, including seborrhea and mild hirsutism
  • In practice this drug is used for any teen or adult woman with acne. It is frequently used in combination with topical and other systemic medication. It is useful as a maintainance therapy post Isotretinoin in adult onset acne

*The acne severity grading should take into account clinical assessment and psychological impact on the patient

Patient Profile

Suitable Candidates

  • Women who have acne associated or not with signs of hyperandrogenism
  • Any woman who has acne that is not controlled with topical medication
  • Used as a contraceptive during the use and after treatment with oral Isotretinoin. In Canada the drug is labelled for acne treatment but is entirely effective as a contraceptive and is indeed licensed as such in many countries
  • Women whose acne has flared after adolescence

Unsuitable Candidates

  • As with all estrogen/progestogen combinations, Diane-35® should not be prescribed to women who have thrombophlebitis, thromboembolic disorders or a history of these conditions
  • Women who wish to use Diane-35® for its contraceptive properties alone
  • Women who have any contraindication to the use of the birth control pill

Women who have:

  • unusual vaginal bleeding that has not yet been diagnosed
  • blood clots in the legs, lungs, eyes or elsewhere
  • a history of stroke, heart attack or chest pain
  • known or suspected cancer of the breast or sex organs
  • liver tumor associated with the use of the pill or other estrogen-containing products
  • jaundice or liver disease
  • Women who smoke and are older than 35 should use an alternate treatment for acne due to the increased risk of circulatory and metabolic complications with oral contraceptives