Drug utilization study of cyproterone/ethinylestradiol (Diane®-35 and generics) in the Netherlands, UK and Italy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31117
• EU PAS number:
  EUPAS8412
• Study ID:
  31117
• Official title and acronym:
  Drug utilization study of cyproterone/ethinylestradiol (Diane®-35 and generics) in the Netherlands, UK and Italy
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Netherlands

  Spain
• Study description:
  The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).
• Study status:
  Finalised

Research institutions and networks

Institutions

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Italy HIS: The Health Search institute

Networks

PHARMO: Database Network Netherlands

Study timelines

Date when funding contract was signed

Actual: 01/12/2014

Study start date

Planned: 01/02/2015

Actual: 01/05/2015

Date of final study report

Planned: 30/01/2016

Actual: 31/03/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer

Study protocol

Initial protocol

17660_Study Protocol DUS Diane_2014-09-12

Updated protocol

17660_02_Protocol_V7.0_2017_extension study

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)