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

Primary Purpose

Vasomotor Symptoms

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

fezolinetant

placebo

About this trial

This is an interventional treatment trial for Vasomotor Symptoms focused on measuring ESN364, menopause, fezolinetant, vasomotor symptoms

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

fezolinetant

placebo fezolinetant

Arm Description

Participants will receive 2 tablets of fezolinetant once daily for 24 weeks.

Participants will receive 2 tablets of matching placebo once daily for 24 weeks.

Outcomes

Primary Outcome Measures

Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 24

Frequency of moderate or severe VMS events will be calculated as the sum of moderate to severe VMS events per day.

Secondary Outcome Measures

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

The severity of VMS will be calculated using a weighted average of VMS events.

Mean change in the patient-reported sleep disturbance by the PROMIS SD SF 8b total score from baseline to week 24

The Patient-reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health Roadmap initiative designed to improve participant-reported outcome (PRO) measures using state-of-the-science methods. 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 participant's experience of sleep disturbance, the measure does not focus on specific sleep-disorder symptoms or ask patients 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 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).

Mean change in the frequency of moderate to severe VMS

Frequency of moderate or severe VMS events will be calculated as the sum of moderate to severe VMS events per day.

Mean change in the severity of moderate to severe VMS

The severity of VMS will be calculated using a weighted average of VMS events.

Mean percent change in the frequency of moderate and severe VMS

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Mean percent change will be reported.

Percent reduction ≥ 50% in the frequency of moderate and severe VMS

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction ≥ 50% will be reported.

Percent reduction ≥ 75% in the frequency of moderate and severe VMS

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction ≥ 75% will be reported.

Percent reduction at 100% in the frequency of moderate and severe VMS

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction 100% will be reported.

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant, temporally associated with the use of study Investigational Product (IP), whether or not considered related to the study IP. An AE can therefore be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures. A TEAE is defined as AE observed after starting administration of the study drug and 21 days after the last dose of study drug.

Number of participants with laboratory value abnormalities and/or adverse events (AEs)

Number of participants with potentially clinically significant laboratory values.

Number of participants with vital sign abnormalities and/or adverse events (AEs)

Number of participants with potentially clinically significant vital sign values.

Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

Number of participants with potentially clinically significant 12-lead ECG values.

Full Information

NCT ID

NCT05033886

First Posted

September 1, 2021

Last Updated

May 10, 2023

Sponsor

Astellas Pharma Global Development, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05033886

Brief Title

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

Acronym

Daylight

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

October 25, 2021 (Actual)

Primary Completion Date

March 27, 2023 (Actual)

Study Completion Date

April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Global Development, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vasomotor Symptoms

Keywords

ESN364, menopause, fezolinetant, vasomotor symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

453 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fezolinetant

Arm Type

Experimental

Arm Description

Participants will receive 2 tablets of fezolinetant once daily for 24 weeks.

Arm Title

placebo fezolinetant

Arm Type

Placebo Comparator

Arm Description

Participants will receive 2 tablets of matching placebo once daily for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

fezolinetant

Other Intervention Name(s)

ESN364

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral

Primary Outcome Measure Information:

Title

Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 24

Description

Frequency of moderate or severe VMS events will be calculated as the sum of moderate to severe VMS events per day.

Time Frame

Baseline to week 24

Secondary Outcome Measure Information:

Title

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

Description

The severity of VMS will be calculated using a weighted average of VMS events.

Time Frame

Baseline to week 24

Title

Mean change in the patient-reported sleep disturbance by the PROMIS SD SF 8b total score from baseline to week 24

Description

Time Frame

Baseline to week 24

Title

Mean change in the frequency of moderate to severe VMS

Description

Frequency of moderate or severe VMS events will be calculated as the sum of moderate to severe VMS events per day.

Time Frame

Baseline to weeks 1, 4, 8, 12, 16 and 20

Title

Mean change in the severity of moderate to severe VMS

Description

The severity of VMS will be calculated using a weighted average of VMS events.

Time Frame

Baseline to weeks 1, 4, 8, 12, 16 and 20

Title

Mean percent change in the frequency of moderate and severe VMS

Description

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Mean percent change will be reported.

Time Frame

Baseline to weeks 1, 4, 8, 12, 16, 20 and 24

Title

Percent reduction ≥ 50% in the frequency of moderate and severe VMS

Description

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction ≥ 50% will be reported.

Time Frame

Baseline to weeks 1, 4, 8, 12, 16, 20 and 24

Title

Percent reduction ≥ 75% in the frequency of moderate and severe VMS

Description

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction ≥ 75% will be reported.

Time Frame

Baseline to weeks 1, 4, 8, 12, 16, 20 and 24

Title

Percent reduction at 100% in the frequency of moderate and severe VMS

Description

Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction 100% will be reported.

Time Frame

Baseline to weeks 1, 4, 8, 12, 16, 20 and 24

Title

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Up to week 27

Title

Number of participants with laboratory value abnormalities and/or adverse events (AEs)

Description

Number of participants with potentially clinically significant laboratory values.

Time Frame

Up to week 27

Title

Number of participants with vital sign abnormalities and/or adverse events (AEs)

Description

Number of participants with potentially clinically significant vital sign values.

Time Frame

Up to week 24

Title

Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

Description

Number of participants with potentially clinically significant 12-lead ECG values.

Time Frame

Up to week 24

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Executive Medical Director

Organizational Affiliation

Astellas Pharma Global Development, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Site BE32005

City

Tienen

State/Province

Vlaams Brabant

ZIP/Postal Code

3300

Country

Belgium

Facility Name

Site CA15008

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Site CA15010

City

London

State/Province

Ontario

ZIP/Postal Code

N5W 6A2

Country

Canada

Facility Name

Site CA15003

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Site CA15012

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Facility Name

Site CA15014

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

Site CA15011

City

Saint Charles Borromeee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Site CA15001

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1L 0H8

Country

Canada

Facility Name

Site CA15005

City

Victoriaville

State/Province

Quebec

ZIP/Postal Code

G6P 6P6

Country

Canada

Facility Name

Site CA15002

City

Quebec

ZIP/Postal Code

G1S 2L6

Country

Canada

Facility Name

Site CA15009

City

Quebec

ZIP/Postal Code

G1S 2L6

Country

Canada

Facility Name

Site CA15007

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Site CZ42007

City

Tabor 3

State/Province

Jihocesky

ZIP/Postal Code

39003

Country

Czechia

Facility Name

Site CZ42002

City

Vodnany

State/Province

Jihocesky

ZIP/Postal Code

389 01

Country

Czechia

Facility Name

Site CZ42008

City

Brno

ZIP/Postal Code

603 00

Country

Czechia

Facility Name

Site CZ42010

City

Ceske Budejovice

ZIP/Postal Code

37001

Country

Czechia

Facility Name

Site CZ42005

City

Cheb

ZIP/Postal Code

350 02

Country

Czechia

Facility Name

Site CZ42009

City

Hradec Kralove

ZIP/Postal Code

500 02

Country

Czechia

Facility Name

Site CZ42011

City

Nachod

ZIP/Postal Code

54701

Country

Czechia

Facility Name

Site CZ42003

City

Olomouc

ZIP/Postal Code

772 00

Country

Czechia

Facility Name

Site CZ42004

City

Pisek

ZIP/Postal Code

397 01

Country

Czechia

Facility Name

Site CZ42006

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Site DK45003

City

Gandrup

State/Province

Nordjylland

ZIP/Postal Code

9362

Country

Denmark

Facility Name

Site DK45002

City

Odense

State/Province

Syddanmark

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Site DK45004

City

Vejle

State/Province

Syddanmark

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Site DK45005

City

Arhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Site FI35801

City

Kuopio

ZIP/Postal Code

02200

Country

Finland

Facility Name

Site FI35803

City

Oulu

ZIP/Postal Code

02200

Country

Finland

Facility Name

Site FR33003

City

La Rochelle

ZIP/Postal Code

17000

Country

France

Facility Name

Site FR33001

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Site DE49004

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Site DE49005

City

Hamburg

ZIP/Postal Code

22159

Country

Germany

Facility Name

Site DE49002

City

Leipzig

ZIP/Postal Code

10026

Country

Germany

Facility Name

Site DE49008

City

Muechen

ZIP/Postal Code

12092

Country

Germany

Facility Name

Site DE49006

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Site HU36002

City

Debrecen

ZIP/Postal Code

4024

Country

Hungary

Facility Name

Site HU36004

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Site HU36001

City

Szekesfeherver

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Site IT39002

City

Bologna

ZIP/Postal Code

12081

Country

Italy

Facility Name

Site IT39006

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Site NL31001

City

Beek

State/Province

Limburg

ZIP/Postal Code

6191 JW

Country

Netherlands

Facility Name

Site NL31004

City

Rotterdam

ZIP/Postal Code

3051 GV

Country

Netherlands

Facility Name

Site NO47001

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Site PL48001

City

Szczecin

State/Province

Zachodniopomorskie

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Site PL48003

City

Bialystok

ZIP/Postal Code

15-224

Country

Poland

Facility Name

Site PL48013

City

Bydgoszcz

ZIP/Postal Code

85-048

Country

Poland

Facility Name

Site PL48006

City

Katowice

ZIP/Postal Code

40-065

Country

Poland

Facility Name

Site PL48011

City

Katowice

ZIP/Postal Code

40-156

Country

Poland

Facility Name

Site PL48004

City

Katowice

ZIP/Postal Code

40-301

Country

Poland

Facility Name

Site PL48007

City

Lublin

ZIP/Postal Code

20-064

Country

Poland

Facility Name

Site PL48009

City

Siedice

ZIP/Postal Code

08-110

Country

Poland

Facility Name

Site PL48017

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Site PL48012

City

Skorzewo

ZIP/Postal Code

60185

Country

Poland

Facility Name

Site PL48010

City

Zamosc

ZIP/Postal Code

22 400

Country

Poland

Facility Name

Site ES34002

City

Alcobendas

ZIP/Postal Code

28100

Country

Spain

Facility Name

Site ES34005

City

Centellas

ZIP/Postal Code

8540

Country

Spain

Facility Name

Site ES34003

City

Leganes

ZIP/Postal Code

28915

Country

Spain

Facility Name

Site ES34001

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Site SE46004

City

Qerebro

ZIP/Postal Code

435 33

Country

Sweden

Facility Name

Site SE46003

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Facility Name

Site SE46002

City

Uppsala

ZIP/Postal Code

435 33

Country

Sweden

Facility Name

Site TR90002

City

Konak

State/Province

Izmir

ZIP/Postal Code

35020

Country

Turkey

Facility Name

Site TR90001

City

Ankara

State/Province

Mamak

ZIP/Postal Code

06620

Country

Turkey

Facility Name

Site TR90008

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Site GB44007

City

Corby

State/Province

Northamptonshire

ZIP/Postal Code

NN18 9EZ

Country

United Kingdom

Facility Name

Site GB44004

City

Shipley

State/Province

Yorkshire

ZIP/Postal Code

BD18 3SA

Country

United Kingdom

Facility Name

Site GB44002

City

Coventry

ZIP/Postal Code

CV3 4FJ

Country

United Kingdom

Facility Name

Site GB44006

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Site GB44003

City

Orpington

ZIP/Postal Code

BR5 3QG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing URL

https://www.clinicalstudydatarequest.com/

Learn more about this trial

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

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

Vasomotor Symptoms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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