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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000095914

  Antiandrogens and estrogens

Population studied

• Short description of the study population:
  New Cyproterone Acetate / Ethinylestradiol (CPA/EE) users in 2011 and 2012.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Characterization of 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 contracep
• Outcomes:
  1. Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne2. Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism3. Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome), 1. Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.2. Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives
• Data analysis plan:
  Patient, treatment and diagnosis characteristics will be reported descriptively. Categorical data will be presented as counts (n) and proportions (%). Continuous data will be presented as means with standard deviation (SD) and as medians with inter quartile range (IQR) when appropriate. Results will be presented for the 2011/2012 users together and stratified by year of diagnosis.

Documents

Results tables

17660_EU-PAS_Abstract

17660_Study Report DUS Diane - final

Study report

17660_04_Report

17660_04_Report extension

17660_04_Report_ 1_interim

Study, other information

17660_04_Report.pdf

17660_04_Report_ 1_interim.pdf