Long-term International Dual-Source Endometriosis and Adenomyosis Registry (LIDEA Registry)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Healthcare resource utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other

Population studied

• Age groups:
  • Adolescents (12 to < 18 years)
  • 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)
• Estimated number of subjects:
  14000

Study design details

• Main study objective:
  Epidemiological assessment of the course of pelvic pain and the development of endometriosis and/or adenomyosis./Examine treatment pathways and outcomes of pelvic pain with or without specific diagnoses (e.g. endometriosis, adenomyosis) including health economic outcomes./Examine the relationship between changes in patient-reported outcome (PRO) measures and healthcare resources utilization.
• Outcomes:
  See above, Effect of therapies on pain/Effect of therapies on bleeding/Identification of therapeutic gaps/Situational analysis of treatment across geographies and countries/Operative vs. medical treatment/National preferences regarding diagnostic and therapeutic pathways, physician perception of successful disease management/Impact of disease and different treatments on work, partnership etc.
• Data analysis plan:
  ZEG Berlin will develop a written Statistical Analysis Plan (SAP) covering the annual progress reporting according to the Study Protocol. A draft SAP including TLFs (tables, listings, figures) will be provided by ZEG Berlin to the Scientific Governance Board for review within 6 months of the study start. The SAP will describe the analysis variable derivation and statistical methodology of planned study reports.