DARWIN EU® - Incidence and characterisation of polyendocrine metabolic ovarian syndrome in Europe

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Polycystic ovarian syndrome
• Additional medical condition(s):
  Polyendocrine metabolic ovarian syndrome

Population studied

• Short description of the study population:
  The study population will include all female individuals with the date of first PMOS diagnosis (index date) within the study period from 01/01/2010 to 31/12/2024.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

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

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  Population-level descriptive disease epidemiology study (Objectives 1, 4, and 5); Patient-level characterisation (Objectives 2 and 3);
• Main study objective:
  1. To estimate the incidence of recorded PMOS diagnoses over time.; 2. To characterise individuals with PMOS at the time of recorded diagnosis in terms of age and pre-defined comorbidities.; 3. To characterise individuals with PMOS in terms of pre-defined non-infertility drug treatments received following diagnosis.; 4. To estimate the incidence rate of infertility, cardiovascular, and mental health outcomes in individuals with PMOS.; 5. To estimate the 5-year and 10-year cumulative incidence of infertility, cardiovascular, and mental health outcomes in individuals with PMOS.;