Recruiting

Fezolinetant

Sponsor:

Astellas Pharma Europe Ltd.

Code:

NCT07602530

Conditions

Hot Flashes

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Fezolinetant

Study Details

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

Study ID

NCT07602530

Start date

Oct 23, 2025

Status verified date

May, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

238 participants

Anticipated

Interventions and Outcome Measures

Arms

Fezolinetant

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

Interventions

Fezolinetant

Oral

Primary outcome measure

  • Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Astellas Pharma Europe Ltd.

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

Locations

Site CA15002

Recruiting

Montreal, Canada

Site CA15001

Recruiting

Prince Albert, Canada

More Information

Sponsor

Astellas Pharma Europe Ltd.

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Menopausal symptoms
  • vasomotor symptoms
  • ESN364
  • fezolinetant
  • VEOZAH®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Astellas Pharma Europe Ltd. on 2026-05-22.