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Recruiting NCT07602530

A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice

— Observational Hot Flashes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fezolinetant.
Who it may be relevant to
Registry conditions: Hot Flashes. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Real-world Observational Study of Outcomes Among Canadian Women With Bothersome VMS Associated With Menopause Who Are Treated With Fezolinetant in a Real-life Setting According to Routine Healthcare Practice

Overview

This study is for women in Canada who are in menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Their own doctor has prescribed fezolinetant for hot flashes and night sweats, as part of routine health care in Canada. In this study, women will be taking tablets of fezolinetant. This study is about recording information only. The women's own doctor decides on treatment, not the study sponsor (Astellas). Women are taking fezolinetant every day for up to 52 weeks (1 year). The main aim is to learn if fezolinetant improves hot flashes and night sweats after 12 weeks. Other aims are to learn if fezolinetant improves hot flashes and night sweats throughout the study. This includes improved sleep and the women's wellbeing. Details are recorded on how satisfied the women are with fezolinetant and if they completed their treatment. This includes reasons for stopping treatment. Any safety issues are recorded. Details about other treatments taken before or with fezolinetant are also recorded.

Interventions

  • Drug Fezolinetant
    Oral

Primary outcome measures

  • Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS [Time frame: Week 12]
Secondary outcome measures (12)
  • Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS [Time frame: Up to Week 24]
  • Change from baseline in menopause-related quality of life due to VMS: Hot Flash Related Daily Interference Scale (HFRDIS) [Time frame: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep disturbance: PROMIS SD SF 8b raw score [Time frame: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep disturbance: Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) total t-score [Time frame: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep disturbance: PGI-C sleep disturbance (SD) [Time frame: Baseline, Week 4, 12 and 24]
  • Change from baseline in Patient Global Impression of Severity (PGI-S) SD [Time frame: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep-related impairment: PROMIS SRI SF 8a raw score [Time frame: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep-related impairment: PROMIS SRI SF 8a total t-score [Time frame: Baseline, Week 4, 12, 24 and 52]
  • Change in treatment satisfaction: Treatment Satisfaction-Visual Analog Scale (TS-VAS) [Time frame: Up to Week 24]
  • Adherence of fezolinetant: Treatment Compliance-Visual Analog Scale (TC-VAS) [Time frame: Up to Week 52]
  • Reasons for treatment initiation of fezolinetant [Time frame: Day 1]
  • Treatment discontinuation rate [Time frame: Up to Week 52]

Eligibility criteria

Inclusion criteria

  • Participant lives in Canada.
  • Participant is experiencing VMS associated with menopause.
  • Participant is newly prescribed fezolinetant as part of routine clinical care but has not yet initiated the first dose. The decision to prescribe fezolinetant must be made prior to and independent of study participation.
  • Participant has acceptable hepatic function test results within the past 3 months prior to taking the first dose as described in the fezolinetant label.
  • Participant is a fluent speaker of English or French.
  • Participant is able to use digital devices and has access to an internet-capable device such as a mobile device or computer.

Exclusion criteria

  • A participant will be excluded if they have contraindications as described in the fezolinetant label.
  • A participant will be excluded if they were previously treated with fezolinetant by a physician.
  • A participant will be excluded if they have been clinically diagnosed with a sleep disorder (e.g., insomnia, narcolepsy) and/or is taking medication to improve a sleep disorder not associated with VMS (i.e., a participant with sleep disturbance associated with VMS is eligible).
  • A participant will be excluded if they are currently participating in an interventional study or previously participated in another interventional study within 6 months of the first dose of fezolinetant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 2 centers
  • Site CA15002 — Montreal
  • Site CA15001 — Prince Albert

Identifiers

NCT: NCT07602530 · 2693-MA-3603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗