Drug utilization of Intrarosa (6.5 mg prasterone pessary) in European Countries (ERC-243)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  INTRAROSA
• Medical condition to be studied:
  Atrophic vulvovaginitis

Population studied

• Short description of the study population:
  Patients with atrophic vulvovaginitis received treatment with intrarosa (6.5 mg prasterone pessary) in European Countries.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrophic vulvovaginitis
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  1-Describe the baseline and historical characteristics of female patients initiating Intrarosa. 2-Estimate the proportion of patients that may have been prescribed Intrarosa outside of the specifications of the product label (‘off-label use’).
• Data analysis plan:
  The analyses will be descriptive in nature, performed annually for 3 years, and use counts and percentages for categorical variables and means with standard deviations for continuous variables. Analyses will be performed both for annual and cumulative study periods separately per database and country. Once multiple years of data are available, trends over time will also be reported. In addition, the aggregated number of patients with the correct indication or with pre-existing contraindications as well as potential off-label use will be presented for all countries.