DARWIN EU® - Treatment patterns in postmenopausal women in European countries: A real-world observational study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study topic, other:
  Post-menopause
• 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

• Anatomical Therapeutic Chemical (ATC) code:
  (G03CA) Natural and semisynthetic estrogens, plain

  Natural and semisynthetic estrogens, plain

  (G03CB) Synthetic estrogens, plain

  Synthetic estrogens, plain

  (G03D) PROGESTOGENS

  PROGESTOGENS

Population studied

• Short description of the study population:
  The study population will include postmenopausal women defined as i) women aged 50 to 65 years and ii) ; women aged <50 years with a prior history of conditions or procedures indicating premature or early ; menopause. This definition will be applied consistently across study objectives.
• Age groups:
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)

Study design details

• Study design:
  A retrospective cohort study will be conducted using routinely collected health data from 5 data sources ; from 4 European countries belonging to 3 EU member states.
• Main study objective:
  The specific objectives of this study are: ; 1. To describe the demographic and clinical characteristics of postmenopausal women, including: ; a) age, ; b) body mass index (BMI), ; c) smoking status, ; d) concomitant conditions, ; e) HRT used at treatment initiation, where applicable. ; Estimates will be stratified by HRT status and presented for selected calendar years. ; 2. To estimate annual prevalence of HRT use among postmenopausal women, overall and ; stratified by: ; a) HRT formulation. ; b) route of administration (systemic or local). ; c) HRT type (natural or synthetic) (if feasible). ; Estimates will additionally be stratified by age group at treatment initiation. ; 3. To estimate the duration of HRT use among postmenopausal women initiating HRT, overall, and ; by age group. ; 4. To describe HRT treatment patterns among postmenopausal women over ten years following ; HRT initiation, overall, and by age group.
• Outcomes:
  The outcomes are as follows: ; • Characterisation of postmenopausal women initiating HRT treatment or not on HRT (objective ; 1). ; • Annual prevalence of HRT use among postmenopausal women, including formulations, route of ; administration, and type of HRT (if feasible) (objective 2). ; • Duration of HRT treatment among postmenopausal women (objective 3). ; • Treatment patterns following HRT treatment initiation (objective 4).