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

NCT ID: NCT05033886

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2023-04-20

Brief 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.

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.

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).

Conditions

Vasomotor Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fezolinetant

Participants receive fezolinetant 45 milligrams (mg) (one 30 mg tablet and one 15 mg tablet) orally once daily for 24 weeks of treatment.

Group Type: EXPERIMENTAL

fezolinetant

Intervention Type: DRUG

oral

placebo

Participants receive placebo matched to fezolinetant tablets orally once daily for 24 weeks of treatment.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

oral

Interventions

fezolinetant

oral

Intervention Type: DRUG

placebo

oral

Intervention Type: DRUG

Other Intervention Names

ESN364

Eligibility Criteria

Inclusion Criteria

• 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.
• 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).

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Executive Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

Site BE32005

Tienen, Vlaams Brabant, Belgium

Site CA15008

Brampton, Ontario, Canada

Site CA15010

London, Ontario, Canada

Site CA15003

Sarnia, Ontario, Canada

Site CA15012

Montreal, Quebec, Canada

Site CA15014

Québec, Quebec, Canada

Site CA15011

Saint Charles Borromeee, Quebec, Canada

Site CA15001

Sherbrooke, Quebec, Canada

Site CA15005

Victoriaville, Quebec, Canada

Site CA15002

Québec, , Canada

Site CA15009

Québec, , Canada

Site CA15007

Québec, , Canada

Site CZ42007

Tábor, Jihočeský kraj, Czechia

Site CZ42002

Vodňany, Jihočeský kraj, Czechia

Site CZ42008

Brno, , Czechia

Site CZ42005

Cheb, , Czechia

Site CZ42010

České Budějovice, , Czechia

Site CZ42009

Hradec Králové, , Czechia

Site CZ42011

Náchod, , Czechia

Site CZ42003

Olomouc, , Czechia

Site CZ42004

Písek, , Czechia

Site CZ42006

Prague, , Czechia

Site DK45003

Gandrup, North Denmark, Denmark

Site DK45002

Odense, Region Syddanmark, Denmark

Site DK45004

Vejle, Region Syddanmark, Denmark

Site DK45005

Arhus C, , Denmark

Site FI35801

Kuopio, , Finland

Site FI35803

Oulu, , Finland

Site FR33003

La Rochelle, , France

Site FR33001

Nantes, , France

Site DE49004

Hamburg, , Germany

Site DE49005

Hamburg, , Germany

Site DE49002

Leipzig, , Germany

Site DE49008

Muechen, , Germany

Site DE49006

Schwerin, , Germany

Site HU36002

Debrecen, , Hungary

Site HU36004

Kecskemét, , Hungary

Site HU36001

Szekesfeherver, , Hungary

Site IT39002

Bologna, , Italy

Site IT39006

Pavia, , Italy

Site NL31001

Beek, Limburg, Netherlands

Site NL31004

Rotterdam, , Netherlands

Site NO47001

Hamar, , Norway

Site PL48001

Szczecin, West Pomeranian Voivodeship, Poland

Site PL48003

Bialystok, , Poland

Site PL48013

Bydgoszcz, , Poland

Site PL48006

Katowice, , Poland

Site PL48011

Katowice, , Poland

Site PL48004

Katowice, , Poland

Site PL48007

Lublin, , Poland

Site PL48009

Siedice, , Poland

Site PL48017

Skierniewice, , Poland

Site PL48012

Skorzewo, , Poland

Site PL48010

Zamość, , Poland

Site ES34002

Alcobendas, , Spain

Site ES34005

Centellas, , Spain

Site ES34003

Leganés, , Spain

Site ES34001

Madrid, , Spain

Site SE46004

Qerebro, , Sweden

Site SE46003

Stockholm, , Sweden

Site SE46002

Uppsala, , Sweden

Site TR90002

Konak, İzmir, Turkey (Türkiye)

Site TR90001

Ankara, Mamak, Turkey (Türkiye)

Site TR90008

Izmir, , Turkey (Türkiye)

Site GB44007

Corby, Northamptonshire, United Kingdom

Site GB44004

Shipley, Yorkshire, United Kingdom

Site GB44002

Coventry, , United Kingdom

Site GB44006

Northwood, , United Kingdom

Site GB44003

Orpington, , United Kingdom

Countries

Belgium; Canada; Czechia; Denmark; Finland; France; Germany; Hungary; Italy; Netherlands; Norway; Poland; Spain; Sweden; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39557487 (View on PubMed)

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=14505&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website.

https://www.clinicaltrials.astellas.com/study/2693-CL-0312/

Link to results and other applicable study documents on the Astellas Clinical Trials website.

Other Identifiers

2021-001685-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2693-CL-0312

Identifier Type: -

Identifier Source: org_study_id