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

NCT07455812 | Active Not Recruiting

• 2 other identifiers: 2693-MA-3549EUPAS1000000132
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hot Flashes

Keywords

Menopausal symptoms; ESN364; vasomotor symptoms; fezolinetant; Hot Flashes; Night sweats; Non-hormonal treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of participants reporting improvement in hot flushes/night sweats measured by PGI-C VMS

  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

  Baseline, Week 12 and Week 24

• Chage from baseline in menopause-related quality of life (MENQoL) total score

  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)

  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

  Baseline, Week 12 and Week 24

Study Arms (1)

Fezolinetant

Participants who are prescribed fezolinetant for the treatment of vasomotor symptoms (VMS) associated with menopause.

Drug: Fezolinetant

Interventions

Fezolinetant DRUG

Oral

Also known as: ESN364

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

Site DE49001

Berlin, Germany

Location

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

Study Design

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

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: October 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)