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Vasomotor SymptomsPhase 3DaylightNCT05033886

A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

A Phase 3 study testing fezolinetant in people with Vasomotor Symptoms, run by Astellas Pharma Global Development, Inc. at 69 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Vasomotor Symptoms
What is being tested?
fezolinetant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
453 participants
Where
69 sitesin 16 countries
Study dates
8 Nov 2021to 20 Apr 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per one of the following criteria at the screening visit:
  • Spontaneous amenorrhea for >= 12 consecutive months
  • Spontaneous amenorrhea for >= 6 months with biochemical criterion of menopause (follicle-stimulating hormone [FSH] > 40 IU/L)
  • Had bilateral oophorectomy >= 6 weeks prior to the screening visit (with or without hysterectomy)
  • Participant has VMS and is unsuitable to receive hormone replacement therapy (HRT) (HRT contraindicated, HRT caution, HRT stoppers and HRT averse participants).
  • Participant has a minimum average of 7 moderate to severe hot flash's (HFs) (VMS) per day as recorded in the electronic diary during the last 10 days prior to randomization.
Show all 9Show fewer
  • Participant is in good general health as determined on the basis of medical history, general physical examination, laboratory and other medical assessments.
  • Participant has a negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody screens).
  • Had hysterectomy without oophorectomy and who meets the biochemical criterion of menopause (FSH > 40 IU/L).

Who cannot join

  • Participant uses a prohibited therapy for VMS (e.g., prescription, over-the-counter or herbal) prior to screening and for the duration of treatment with investigational product (IP).
  • Participant has known documented substance abuse or alcohol addiction within 6 months of screening.
  • Participant has history of a malignant tumor within the last 5 years, except for basal cell carcinoma.
  • Participant has endometrial thickness > 8 mm on the locally read screening transvaginal ultrasound (TVU) or any clinically significant findings that that would make the participant ineligible.
  • Participant has history of severe allergy, hypersensitivity or intolerance to the IP and/or any of its excipients.
  • Participant has a history of seizures or other convulsive disorders unless well controlled.
Show all 14Show fewer
  • Participant has a medical condition or chronic disease (including history of neurological [including cognitive], renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.
  • Participant has any of the following: active liver disease, jaundice, elevated liver aminotransferases at screening (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total bilirubin (TBL) or direct bilirubin (DBL) > 1.5 × upper limit of normal (ULN), elevated International Normalized Ratio (INR) > 1.5 (unless participant is receiving anticoagulant therapy) or elevated alkaline phosphatase (ALP). Participants with mildly elevated ALT or AST up to 1.5 × ULN can be enrolled if TBL and DBL are normal. Participants with mildly elevated ALP (up to 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participants with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.
  • Participant has creatinine > 1.5 × ULN or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula <= 59 mL/min per 1.73 m^2 at the screening visit.
  • Participant has a history of suicide attempt or suicidal behavior within the last 12 months.
  • Participant has participated in another interventional study within the last 30 days prior to screening and for the duration of the study.
  • Participant who has been previously enrolled in a clinical study with fezolinetant.
  • Participant is unable or unwilling to complete the study procedures.
  • Participant has any condition makes the participant unsuitable for study participation.

Trial locations and contacts

69 sites in 16 countries.

69 sites in 16 countries

Canada11 sites

  • Site CA15008

    Brampton, Ontario, L6T 0G1

  • Site CA15010

    London, Ontario, N5W 6A2

  • Site CA15012

    Montreal, Quebec, H1M 1B1

  • Site CA15014

    Québec, Quebec, G3K 2P8

  • Site CA15002

    Québec, G1S 2L6

  • Site CA15009

    Québec, G1S 2L6

  • Site CA15007

    Québec, G1W 4R4

  • Site CA15011

    Saint Charles Borromeee, Quebec, J6E 2B4

  • Site CA15003

    Sarnia, Ontario, N7T 4X3

  • Site CA15001

    Sherbrooke, Quebec, J1L 0H8

  • Site CA15005

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Poland11 sites

  • Site PL48003

    Bialystok, 15-224

  • Site PL48013

    Bydgoszcz, 85-048

  • Site PL48006

    Katowice, 40-065

  • Site PL48011

    Katowice, 40-156

  • Site PL48004

    Katowice, 40-301

  • Site PL48007

    Lublin, 20-064

  • Site PL48009

    Siedice, 08-110

  • Site PL48017

    Skierniewice, 96-100

  • Site PL48012

    Skorzewo, 60185

  • Site PL48001

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Site PL48010

    Zamość, 22 400

Other trials in Poland

Czechia10 sites

  • Site CZ42008

    Brno, 603 00

  • Site CZ42010

    České Budějovice, 37001

  • Site CZ42005

    Cheb, 350 02

  • Site CZ42009

    Hradec Králové, 500 02

  • Site CZ42011

    Náchod, 54701

  • Site CZ42003

    Olomouc, 772 00

  • Site CZ42004

    Písek, 397 01

  • Site CZ42006

    Prague, 120 00

  • Site CZ42007

    Tábor, South Bohemian Region, 39003

  • Site CZ42002

    Vodňany, South Bohemian Region, 389 01

Other trials in Czechia

Germany5 sites

  • Site DE49004

    Hamburg, 20253

  • Site DE49005

    Hamburg, 22159

  • Site DE49002

    Leipzig, 10026

  • Site DE49008

    Muechen, 12092

  • Site DE49006

    Schwerin, 19055

Other trials in Germany

United Kingdom5 sites

  • Site GB44007

    Corby, Northamptonshire, NN18 9EZ

  • Site GB44002

    Coventry, CV3 4FJ

  • Site GB44006

    Northwood, HA6 2RN

  • Site GB44003

    Orpington, BR5 3QG

  • Site GB44004

    Shipley, Yorkshire, BD18 3SA

Other trials in United Kingdom

Denmark4 sites

  • Site DK45005

    Arhus C, 8000

  • Site DK45003

    Gandrup, North Denmark, 9362

  • Site DK45002

    Odense, Region Syddanmark, 5000

  • Site DK45004

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Spain4 sites

  • Site ES34002

    Alcobendas, 28100

  • Site ES34005

    Centellas, 8540

  • Site ES34003

    Leganés, 28915

  • Site ES34001

    Madrid, 28041

Other trials in Spain

Hungary3 sites

  • Site HU36002

    Debrecen, 4024

  • Site HU36004

    Kecskemét, 6000

  • Site HU36001

    Szekesfeherver, 8000

Other trials in Hungary

Sweden3 sites

  • Site SE46004

    Qerebro, 435 33

  • Site SE46003

    Stockholm, 17176

  • Site SE46002

    Uppsala, 435 33

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Site TR90001

    Ankara, Mamak, 06620

  • Site TR90008

    Izmir, 35100

  • Site TR90002

    Konak, İzmir, 35020

Other trials in Turkey (Türkiye)

Finland2 sites

  • Site FI35801

    Kuopio, 02200

  • Site FI35803

    Oulu, 02200

Other trials in Finland

France2 sites

  • Site FR33003

    La Rochelle, 17000

  • Site FR33001

    Nantes, 44093

Other trials in France

Italy2 sites

  • Site IT39002

    Bologna, 12081

  • Site IT39006

    Pavia, 27100

Other trials in Italy

Netherlands2 sites

  • Site NL31001

    Beek, Limburg, 6191 JW

  • Site NL31004

    Rotterdam, 3051 GV

Other trials in Netherlands

Belgium1 site

  • Site BE32005

    Tienen, Vlaams Brabant, 3300

Other trials in Belgium

Norway1 site

  • Site NO47001

    Hamar, 2317

Other trials in Norway

About this study

Official title: A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.

The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes.

Read more

Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone.

Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life.

During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.

The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

Being tested
fezolinetant, placebo
Keywords
ESN364, menopause, fezolinetant, vasomotor symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fezolinetantDrug

    Also called ESN364

    oral

  • placeboDrug

    oral

Study groups in NCT05033886
Study groupRoleWhat they receive
fezolinetantExperimentalParticipants receive fezolinetant 45 milligrams (mg) (one 30 mg tablet and one 15 mg tablet) orally once daily for 24 weeks of treatment.
Receives: Drug: fezolinetant
placeboPlacebo comparatorParticipants receive placebo matched to fezolinetant tablets orally once daily for 24 weeks of treatment.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in the frequency of moderate to severe VMS from baseline at week 24

    The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity.

    Measured: Baseline, week 24

Secondary outcomes (9)

  1. Mean change in the severity of moderate to severe VMS from baseline at week 24

    Severity of moderate to severe VMS per day is calculated as follows: [(number of moderate Hot Flashes (HFs) × 2) + (number of severe HFs/day × 3)]/number of daily moderate/severe HFs. Moderate VMS is defined as sensation of heat with sweating but able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, causing cessation of activity. Severity is zero for participants that have had no moderate or severe VMS. Higher score indicates greater severity. A negative change indicates a reduction/improvement.

    Measured: Baseline, week 24

  2. Mean change in the patient-reported sleep disturbance by the Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b total score) from baseline at week 24

    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. Because it assesses the participants experience of sleep disturbance, the measure does not focus on specific sleep-disorder symptoms or ask participants to report objective measures of sleep (e.g., total amount of sleep, time to fall asleep and amount of wakefulness during sleep). Responses to each of the 8 items range from 1 (no disturbed sleep) to 5 (disturbed sleep), and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the disturbed sleep. A negative value indicates a better outcome.

    Measured: Baseline, week 24

  3. Mean change in the frequency of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16 and 20

    The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity.

    Measured: Baseline, weeks 1, 4, 8, 12, 16 and 20

  4. Mean change in severity of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16 and 20

    Severity of moderate to severe VMS per day is calculated as follows: [(number of moderate HFs × 2) + (number of severe HFs/day × 3)]/number of daily moderate/severe HFs. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, causing cessation of activity. Severity is zero for participants that have had no moderate or severe VMS. Higher score indicates greater severity. A negative change indicates a reduction/improvement.

    Measured: Baseline, weeks 1, 4, 8, 12, 16 and 20

  5. Mean percent change in the frequency of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16, 20 and 24

    The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity.

    Measured: Baseline, weeks 1, 4, 8, 12, 16, 20 and 24

  6. Number of participants with percent reduction of >/= 50% in the frequency of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16, 20 and 24

    The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity.

    Measured: Baseline, weeks 1, 4, 8, 12, 16, 20 and 24

  7. Number of participants with percent reduction of >/= 75% in the frequency of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16, 20 and 24

    The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity.

    Measured: Baseline, weeks 1, 4, 8, 12, 16, 20 and 24

  8. Number of participants with percent reduction at 100% in the frequency of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16, 20 and 24

    The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity.

    Measured: Baseline, weeks 1, 4, 8, 12, 16, 20 and 24

  9. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    An AE is any untoward medical occurrence in a participant administered a study drug, which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable \& unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether considered related to MP. A TEAE was defined as an AE observed after starting administration of study intervention and up to 21 days after the last dose of study intervention.

    Measured: From first dose to week 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start8 Nov 2021
  3. Primary completion27 Mar 2023
  4. Study completion20 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033886
Sponsor's protocol ID
2693-CL-0312
Other IDs
2021-001685-38
Acronym
Daylight
Status last verified
Oct 2024
First submitted
1 Sep 2021
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Schaudig K, Wang X, Bouchard C, Hirschberg AL, Cano A, Shapiro C M M, Stute P, Wu X, Miyazaki K, Scrine L, Nappi RE. Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial. BMJ. 2024 Nov 18;387:e079525. doi: 10.1136/bmj-2024-079525.

    PubMed 39557487

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fezolinetant in people with Vasomotor Symptoms, run by Astellas Pharma Global Development, Inc. at 69 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Canada, Poland, Czechia, Germany, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in the frequency of moderate to severe VMS from baseline at week 24 (time frame: Baseline, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05033886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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