Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
This study is designed to compile the reasons and specific indications for the prescription
 of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary
 objective of the study is to characterize the prescribing behaviors for Cyproterone Acetate
 combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France, the
 Netherlands, and Spain), including:

 -  prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol

 -  use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the
 updated label

 -  concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined
 hormonal contraceptives

 -  second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the
 indication acne
Cyproterone acetate (CPA) 2mg, in combination with ethinyl estradiol (EE) 35mcg, is a
 medicinal product currently indicated for the treatment of moderate to severe acne in women
 of reproductive age. Due to the combination with ethinyl estradiol and the dosing, the
 preparations also act as effective contraceptives.

 In 2012, the French health authority conducted a national review of Cyproterone Acetate
 combined with Ethinyl Estradiol and highlighted serious thromboembolic events and extensive
 off-label use of these medicines as a contraceptive only. This triggered an Urgent Union
 Procedure at the beginning of 2013. The European Medicines Agency's Pharmacovigilance Risk
 Assessment Committee (PRAC) concluded that the benefits of Cyproterone Acetate combined with
 Ethinyl Estradiol (cyproterone acetate 2mg / ethinyl estradiol 35mcg) outweigh the risks,
 providing that several measures are taken to minimize the risk of thromboembolism. These
 medicines should be used solely for the treatment of moderate to severe acne related to
 androgen sensitivity and/or hirsutism in women of reproductive age. Since Cyproterone Acetate
 combined with Ethinyl Estradiol acts as a hormonal contraceptive, women should not take these
 medicines in combination with hormonal contraceptives. As one of the risk minimization
 measures, the Market Authorization Holders were required to conduct a number of studies
 including this drug utilization survey.

 This study is a multi-national, cross sectional, prospective, non-interventional, drug
 utilization study conducted in 5 countries. Study participants will be recruited by a network
 of health care professionals. Physicians will collect information from study participants
 based on questionnaires. This is a one-time survey with no follow-up.

 Bayer initiated this study and supports it by an unconditional grant to ZEG. Bayer is not
 actively involved in the study conduct.

 Prolongation of recruitment:

 At the beginning of May 2016 the recruitment was finished in 4 of the 5 European countries in
 which the study is conducted (Austria, Czech Republic, The Netherlands, and Spain). At that
 point in time, only few patients were enrolled in France because of a delayed recruitment
 start. Therefore, it was agreed to extend the recruitment phase in France till January 2017.
 This will ensure that information on the use of Cyproterone Acetate (combined with Ethinyl
 Estradiol) will be collected from all participating countries.
Inclusion Criteria:

 -  Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during
 the study period.

 -  Women who are willing to participate in the drug utilization study

 Exclusion Criteria:

 -  Women who are not willing to sign the informed consent

 -  Women with a language barrier