Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated with Menopause Among Women in a German Real-life Setting

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:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  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:
  The study population will consist of women who are experiencing VMS and have been prescribed fezolinetant for the treatment of VMS associated with menopause via an independent decision by the treating physician as per routine clinical practice.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Menopausal women
• Estimated number of subjects:
  334

Study design details

• Study design:
  This is a decentralized clinical trial, single arm prospective study using Real World Evidence with no Biospecimen Retention.
• Main study objective:
  The goal of this study is to learn about the value of fezolinetant tablets in treating hot flashes and night sweats that women in Germany experience during menopause.
• Setting:
  The women that want to take part in the study will take fezolinetant tablets for their hot flashes and night sweats. This study is about collecting information only. The individual’s doctor decides on treatment, not the study sponsor (Astellas).; The study will last about 6 months (24 weeks). During the study, the women taking part will complete up to 5 virtual reviews. The virtual reviews will ask the women to complete 3 – 5 surveys. ; At the first virtual review the women will be asked about their health and other medicines they have taken or are taking. ; The surveys will ask the women about their hot flashes and night sweats, other menopause symptoms, and how these symptoms affect their health and daily life. ; After the first or second virtual review the women will take their first dose of fezolinetant tablets and continue taking fezolinetant as explained by their doctor. ; The women will have 3 virtual follow-up reviews at about 1 week, 3 months (12 weeks), and 6 months (24 weeks) after their first dose of fezolinetant tablets. The women will be asked when they took their fezolinetant tablets or if they stopped taking them.
• Comparators:
  None
• Outcomes:
  Primary: ; • Response of “moderately better” or “much better” at week 24, measured by Patient Global Impression of Change of Vasomotor Symptoms (PGI-C VMS); ; Secondary: ; • Response of “moderately better” or “much better” at week 1 and week 12, measured by PGI-C VMS; • Change on the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall vasomotor symptoms (VMS) domain score from baseline to week 12 and from baseline to week 24; • Change on the MENQOL 1-week recall total score (full questionnaire) from baseline to week 12 and from baseline to week 24; • Response of “moderately better” or “much better” at weeks 1, 12 and 24, measured by the Patient Global Impression of Change of Sleep Disturbance (PGI-C SD); • Change on the Patient-Reported Outcomes Measurement Information System, Sleep Disturbance - short Form 8b (PROMIS SD SF 8b) total score from baseline to week 12 and from baseline to week 24; • Response of “very satisfied”, “somewhat satisfied”, “undecided”, “somewhat unsatisfied” or “very unsatisfied” on treatment satisfaction at week 12 and week 24; • Discontinuation of fezolinetant (yes/no); • Reason for discontinuation; • Treatment switching for VMS associated with menopause (yes/no); • Occurrence of each adverse event (AE) (yes/no); • Occurrence of each SAE (yes/no)
• Data analysis plan:
  This is a single arm, non-interventional observational study, with no hypothesis testing. The sample size is based on primary estimands and assumes approximately 25% discontinuation prior to week 24.; ; The primary estimand is the Treatment Policy estimand, which ignores intercurrent events, including changes in treatment. Missing data will be imputed.; ; Supplemental analyses are proposed, to use a Hypothetical estimand (data occurring after intercurrent events are set to missing), and a Composite estimand (any occurrence of an intercurrent event leads to the participant being considered a non-responder).