An observational study in Hot Flashes, sponsored by Astellas Pharma Europe Ltd.. Completed at 1 site in Germany. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · Observational
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's enrollment of 105 is close to the median of 97 across 18 observational studies indexed under Hot Flashes.
Browse Hot Flashes studies →Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who are prescribed fezolinetant for the treatment of VMS associated with menopause in a real-world setting as part of routine clinical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who are prescribed fezolinetant for the treatment of vasomotor symptoms (VMS) associated with menopause.
Drug: Fezolinetant
Oral
Also known as: ESN364
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.
Time frame: Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, Week 12 and Week 24
Treatment satisfaction
Treatment satisfaction will be assessed using 1 question that will be created for this study.
Time frame: Up to Week 24
Number of participants who discontinue fezolinetant
Time frame: Up to Week 24
Reasons for discontinuing fezolinetant (including potential switching patterns)
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 24
Plan to share: No — 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/.
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Jul 2026, 20 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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