A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause (GRACE)

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

This study is for women in Germany who are going through menopause. They have symptoms including hot flashes and night sweats (also called vasomotor symptoms). Their doctor has decided to give them fezolinetant tablets to help treat these symptoms. Fezolinetant tablets do not contain hormones. Fezolinetant tablets have been approved in some countries to treat hot flashes and night sweats. Doctors have standard clinical practice guidelines to help them decide how to treat women who are going through menopause and have hot flashes and night sweats. 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. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Fezolinetant

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Site DE49001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who are prescribed fezolinetant for the treatment of VMS associated with menopause in a real-world setting as part of routine clinical care.

Description

Inclusion Criteria:

• Participant has been prescribed fezolinetant for the treatment of VMS associated with menopause according to routine clinical practice
• Participant is living in Germany
• Participant is able to communicate in German language
• Participant is able to use digital tools and have access to an internet-capable device

Exclusion Criteria:

• A patient will be excluded if she is participating in clinical trials.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fezolinetant; Participants who are prescribed fezolinetant for the treatment of vasomotor symptoms (VMS) associated with menopause.	Drug: Fezolinetant; Oral; Other Names: ESN364

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting improvement in hot flushes/night sweats measured by Patient Global Impression of Change of VMS (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 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting improvement in hot flushes/night sweats measured by 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.	Up to Week 12
Change from baseline in VMS in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall Vasomotor domain score	The MENQoL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26) and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to 6 (extremely bothersome) scale.	Baseline, Week 12 and Week 24
Chage from baseline in menopause-related quality of life (MENQoL) total score	The MENQoL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26) and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to 6 (extremely bothersome) scale.	Baseline, Week 12 and Week 24
Change from baseline in sleep disturbance measured by Patient Global Impression of Change of Sleep Disturbance (PGI-C SD)	PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Participant ratings range from (1) much better to (7) much worse.	Baseline, Week 1, Week 12 and Week 24
Change from baseline in total score of Patient-Reported Outcomes Measurement Information System, Sleep Disturbance - Short Form (PROMIS SD SF) 8b	The PROMIS SD SF 8b assesses self-reported sleep disturbance over the past 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).	Baseline, Week 12 and Week 24
Treatment satisfaction	Treatment satisfaction will be assessed using 1 question that will be created for this study.	Up to Week 24
Number of participants who discontinue fezolinetant		Up to Week 24
Reasons for discontinuing fezolinetant (including potential switching patterns)		Up to Week 24
Number of participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have a causal relationship with this treatment.	Up to Week 24
Number of participants with Serious Adverse Events (SAEs)	An adverse event is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death, is life threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, or a medically important event.	Up to Week 24

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Director: Medical Affairs, Astellas Pharma Europe Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: vasomotor symptoms; Menopausal symptoms; ESN364; fezolinetant; Hot Flashes; Night sweats; Non-hormonal treatment
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hot Flashes; fezolinetant
• Other Study ID Numbers: 2693-MA-3549; EUPAS1000000132 (Registry Identifier: HMA-EMA Catalogue of RWD Studies)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No