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

NCT07602530 | Recruiting

• 1 other identifier: 2693-MA-3603
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hot Flashes

Keywords

Menopausal symptoms; vasomotor symptoms; ESN364; fezolinetant; VEOZAH®

Outcome Measures

Primary Outcomes (1)

• Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS

  The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.

  Week 12

Secondary Outcomes (17)

• Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS

  Up to Week 24

• Change from baseline in menopause-related quality of life due to VMS: Hot Flash Related Daily Interference Scale (HFRDIS)

  Baseline, Week 4, 12, 24 and 52

• Change from baseline in sleep disturbance: PROMIS SD SF 8b raw score

  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

  Baseline, Week 4, 12, 24 and 52

• Change from baseline in sleep disturbance: PGI-C sleep disturbance (SD)

  Baseline, Week 4, 12 and 24

Study Arms (1)

Fezolinetant

Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.

Drug: Fezolinetant

Interventions

Fezolinetant DRUG

Oral

Also known as: ESN364, VEOZAH

Fezolinetant

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (2)

Site CA15002

Montreal, Canada

RECRUITING

Site CA15001

Prince Albert, Canada

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Interventions

fezolinetant

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Affairs

  Astellas Pharma Europe Ltd.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Europe Ltd.

CONTACT

+1-800-888-7704; astellas.registration@astellas.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start: October 23, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)