Drug Utilization Study on the Prescribing Indications for CPA/EE in 5 European Countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30829
• EU PAS number:
  EUPAS8365
• Study ID:
  30829
• Official title and acronym:
  Drug Utilization Study on the Prescribing Indications for CPA/EE in 5 European Countries
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  France

  Netherlands

  Spain
• Study description:
  Cyproterone acetate (CPA) 2mg, in combination with ethinylestradiol (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 EE and the dosing, the preparations also act as effective contraceptives. This multi-national, cross-sectional drug utilization study is designed to collect the reasons and specific indications for the prescription of CPA/EE. The primary objective of the study is to characterize the prescribing behaviors for CPA/EE in 5 European countries (Austria, Czech Republic, France, the Netherlands, and Spain), which includes the characterization of prescribing indications for CPA/EE, the use of CPA/EE in accordance with the updated label, concomitant use of CPA/EE and combined hormonal contraceptives (CHCs), and second line treatment of CPA/EE in the indication acne. As sample of 50 physicians per country will be asked to enroll a total of 5,000 study participants. Data will be captured via paper-based questionnaires that will be filled out by the participating physicians based on the patient’s statements and medical record information.
• Study status:
  Finalised

Research institutions and networks

Institutions

Berlin Center for Epidemiology & Health Research, ZEG Berlin

Germany

Study timelines

Date when funding contract was signed

Actual: 18/12/2013

Study start date

Planned: 01/02/2015

Actual: 10/03/2015

Date of final study report

Planned: 31/05/2016

Actual: 31/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG

Study protocol

Initial protocol

Drug Utilization Study CPA_Study Protocol_FINAL

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)