A Non-interventional, Longitudinal, Medical Chart Review Study to Characterize Fezolinetant Use, Treatment Patterns and Patient Characteristics of Women Treated for Vasomotor Symptoms in the Private Healthcare Setting in Spain (CARMEN)

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

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  VEOZA
• Study drug International non-proprietary name (INN) or common name:
  FEZOLINETANT
• Anatomical Therapeutic Chemical (ATC) code:
  (G02CX06) fezolinetant

  fezolinetant
• Medical condition to be studied:
  Menopausal symptoms

Population studied

• Short description of the study population:
  This study is about women in Spain who are in menopause. They had symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Their own doctor had prescribed them fezolinetant for hot flashes and night sweats, as part of routine health care in Spain.
• Age groups:
  • 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)
• Estimated number of subjects:
  150

Study design details

• Study design:
  This is an single-arm, retrospective study using Real World Evidence with no Biospecimen Retention.
• Main study objective:
  The goal of this study is to learn more about fezolinetant and other treatments the women took for their hot flashes, before and after taking fezolinetant and to describe their sociodemographic and clinical characteristics.
• Setting:
  This study is about women in Spain who are in menopause. They had symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Their own doctor had prescribed them fezolinetant for hot flashes and night sweats, as part of routine health care in Spain.; This study is about collecting information only. The women’s own doctor decided on treatment, not the study sponsor (Astellas).; In this study, medical records will be reviewed from women who have been prescribed fezolinetant in a private healthcare setting in Spain. This could have been either in a hospital or a private clinic. Information will be collected from before the women took fezolinetant, and for up to 6 months after they started taking fezolinetant.; Researchers will learn more about fezolinetant and other treatments the women took for their hot flashes, before and after taking fezolinetant. They will check if the women had fewer or less severe hot flashes, and if their wellbeing improved. Researchers will also learn about the women’s clinical history, background, and lifestyle. Safety information will also be collected.
• Comparators:
  none
• Outcomes:
  Primary: ; • To describe the treatment patterns of patients with VMS before and after initiating fezolinetant include MHT, other prescription medication (e.g., antidepressants) and prescription and non- prescription non-hormonal therapy (including supplements and alternative medicine); • To describe the sociodemographic and clinical characteristics of patients with VMS treated with fezolinetant including VMS frequency, severity and duration, other menopause-related symptoms and comorbidities (e.g., vaginal atrophy, osteoporosis and sleep disorders) as well as relevant medical history such as breast cancer and cardiovascular disease; Secondary: ; • To describe treatment patterns and comorbidities in subgroups (by age category, MHT status category and history of breast cancer) of patients with VMS ; • To describe the hepatic-related safety profile and AEs leading to discontinuation of fezolinetant in patients with VMS
• Data analysis plan:
  This is a single arm, non-interventional observational study, with no hypothesis testing. Descriptive statistics (e.g., frequencies and percentages for categorical variables; mean, median, standard deviation, quartiles and minimum and maximum for continuous variables) will be provided.; Graphical representations will be provided according to the nature of the variables, using different types of charts such as Sankey diagrams, as appropriate.