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A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 (Skylight 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003142
Recruitment Status : Active, not recruiting
First Posted : July 1, 2019
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:

This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.

The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes.

Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin.

The study participants will take study treatment for 52 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take the same dose. Women who take placebo during the first 12 weeks will start taking fezolinetant. Their dose will be either low dose or high dose fezolinetant.

At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees.

The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.


Condition or disease Intervention/treatment Phase
Hot Flashes Drug: fezolinetant Drug: placebo Phase 3

Detailed Description:
This study will consist of a screening period and a 52 week treatment period. Safety follow up will occur 3 weeks after the last dose of study drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : July 30, 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: low dose fezolinetant
Participants will receive low dose fezolinetant for 52 weeks.
Drug: fezolinetant
administered orally

Experimental: high dose fezolinetant
Participants will receive high dose fezolinetant for 52 weeks.
Drug: fezolinetant
administered orally

Placebo Comparator: placebo
Participants will receive placebo for 12 weeks, after 12 weeks participants will be re-assigned to either low dose or high dose fezolinetant for 40 weeks.
Drug: placebo
administered orally




Primary Outcome Measures :
  1. Mean change in the frequency of moderate to severe vasomotor symptoms (VMS) from baseline to week 4 [ Time Frame: baseline to week 4 ]
    Frequency of moderate or severe VMS events will be calculated as the sum of moderate to severe VMS events per day.

  2. Mean change in the frequency of moderate to severe VMS from baseline to week 12 [ Time Frame: baseline to week 12 ]
    Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.

  3. Mean change in the severity of moderate to severe VMS from baseline to week 4 [ Time Frame: baseline to week 4 ]
    The severity of VMS will be calculated using a weighted average of VMS events.

  4. Mean change in the severity of moderate to severe VMS from baseline to week 12 [ Time Frame: baseline to week 12 ]
    The severity of VMS will be calculated using a weighted average of VMS events.


Secondary Outcome Measures :
  1. Mean change in the Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) Total Score from baseline to week 12 [ Time Frame: baseline to week 12 ]

    The PROMIS is a National Institutes of Health Roadmap initiative designed to improve PRO measures using state-of-the-science methods. The PROMIS SD SF 8b [PROMIS SD, 2015] 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).


  2. Mean change in the frequency of moderate to severe VMS from baseline to each week up to week 12 [ Time Frame: baseline to week 1, 2, 3, 5, 6, 7, 8, 9, 10, 11 ]
    Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.

  3. Mean change in the severity of moderate to severe VMS from baseline to each week up to week 12 [ Time Frame: baseline to week 1, 2, 3, 5, 6, 7, 8, 9, 10, 11 ]
    The severity of VMS will be calculated using a weighted average of VMS events.

  4. Mean percent reduction in the frequency of moderate and severe VMS from baseline to each week up to week 12 [ Time Frame: baseline to week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
    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.

  5. Percent reduction ≥ 50% in the frequency of moderate and severe VMS from baseline to each week up to week 12 [ Time Frame: baseline to week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
    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.

  6. Percent reduction at 100% in the frequency of moderate and severe VMS from baseline to each week up to week 12 [ Time Frame: baseline to week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
    Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction at 100% will be reported.

  7. Mean change in the frequency of moderate to severe VMS from baseline to week 24 [ Time Frame: baseline to week 24 ]
    Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.

  8. Mean change in the severity of moderate to severe VMS from baseline to week 24 [ Time Frame: baseline to week 24 ]
    The severity of VMS will be calculated using a weighted average of VMS events.

  9. Number of participants with Adverse Events [ Time Frame: Up to 55 weeks ]
    An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

  10. Number of participants with vital sign abnormalities and /or adverse events (AEs) [ Time Frame: Up to 55 weeks ]
    Number of participants with potentially clinically significant vital sign values.

  11. Number of participants with Transvaginal Ultrasound (TVU) abnormalities and/or Adverse Events (AEs) [ Time Frame: Baseline and 52 weeks ]
    Number of participants with potentially clinically significant TVU abnormalities.

  12. Number of participants with endometrial biopsy abnormalities and/or Adverse Events (AEs) [ Time Frame: Baseline and 52 weeks ]
    Number of participants with potentially clinically significant endometrial biopsy abnormalities.

  13. Number of participants with laboratory value abnormalities and/or adverse events (AEs) [ Time Frame: Up to 55 weeks ]
    Number of participants with potentially clinically significant laboratory values.

  14. Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs) [ Time Frame: Up to 52 weeks ]
    Number of participants with potentially clinically significant ECG values.

  15. Score on the Patient Global Impression of Change (PGI-C) in VMS at each visit [ Time Frame: Week 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]

    The Patient Global Impression evaluates the following: (a) patient-perceived severity of a condition (PGI-S) and (2) patient-perceived change from the initiation of treatment (PGI-C).

    PGI scales will be used to evaluate meaningful within-person changes over time in VMS (PGI-C).

    The PGI-C VMS asks: "Compared to the beginning of this study, how would you rate your hot flashes (HFs)/night sweats now?"

    Patient ratings range from (1) much better to (7) much worse.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a body mass index ≥ 18 kg/m^2 and ≤ 38 kg/m^2.
  • Subject must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:

    • Spontaneous amenorrhea for ≥ 12 consecutive months
    • Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] > 40 IU/L); or
    • Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
  • Within the 10 days prior to randomization, subject must have a minimum average of 7 to 8 moderate to severe hot flashes (HFs) vasomotor symptoms (VMS) per day, or 50 to 60 per week.
  • Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG) within the reference range for the population studied, or showing no clinically relevant deviations.
  • Subject has documentation of a normal/negative or no clinically significant findings mammogram (obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
  • Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 end of treatment (EOT), and for subjects who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit.
  • Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT), for subjects with uterine bleeding, and for subjects who are withdrawn from the study prior to completion. The endometrial biopsy obtained at screening must be considered evaluable.
  • Subject has documentation of a normal or not clinically significant Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months or at screening.
  • Subject has a negative urine pregnancy test at screening.
  • Subject has a negative serology panel (i.e. negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.
  • Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

  • Subject uses a prohibited therapy (strong or moderate cytochrome P450 1A2 [CYP1A2] inhibitors, hormone replacement therapy [HRT], hormonal contraceptive or any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue use of such drugs for the full duration of study conduct.
  • Subject has known substance abuse or alcohol addiction within 6 months of screening.
  • Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.
  • Subject's systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is ≥ 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.

    • Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
    • Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
  • Subject has history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
  • Subject has an unacceptable result from the TVU assessment at screening (i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding).
  • Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer or other clinically significant findings at screening.
  • Subject has a history within the last 6 months of undiagnosed uterine bleeding.
  • Subject has a history of seizures or other convulsive disorders.
  • Subject has a medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.
  • Subject has active liver disease, jaundice or elevated liver aminotransferases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total or direct bilirubin, elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 times the upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated total bilirubin may be enrolled as long as direct bilirubin, hemoglobin and reticulocytes are normal.
  • Subject has creatinine > 1.5 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m^2 at screening.
  • Subject has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to question 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale [C-SSRS]), or who is at significant risk to commit suicide at screening and at randomization.
  • Subject has previously been enrolled in a clinical trial with fezolinetant.
  • Subject is participating concurrently in another interventional study or participated in an interventional study within 28 days prior to screening, or received any investigational drug within 28 days or within 5 half-lives prior to screening, whichever is longer.
  • Subject is unable or unwilling to complete the study procedures.
  • Subject has any condition which makes the subject unsuitable for study participation.
  • Subject has had partial or full hysterectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003142


Locations
Hide Hide 93 study locations
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United States, Arizona
Mesa Obstetricians and Gynecologists
Mesa, Arizona, United States, 85209
Precision Trials
Phoenix, Arizona, United States, 85032
Visions Clinical Research - Tuscon
Tucson, Arizona, United States, 85712
United States, California
Excell Research
Oceanside, California, United States, 92056
Dream Team Clinical Research, LLC
Pomona, California, United States, 91767
Clinical Trials Research
Sacramento, California, United States, 95821
Wake Research Associates, LLC
San Diego, California, United States, 92108
Women's Healthcare Affiliates
San Diego, California, United States, 92111
Bayview Research Group
Valley Village, California, United States, 91607
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80209
Horizons Clincial Research Center LLC
Denver, Colorado, United States, 80220
Physicians' Research Options/Red Rocks OB/GYN
Lakewood, Colorado, United States, 80228
United States, Florida
Helix Biomedics
Boynton Beach, Florida, United States, 33436
Renaissance Research and Medical Group, Inc.
Cape Coral, Florida, United States, 33991
Nature Coast Clinical Research
Crystal River, Florida, United States, 34429
Bioclinica Research, Melbourne
Melbourne, Florida, United States, 32940
LCC Medical Research Institute, LLC
Miami, Florida, United States, 33126
Suncoast Clinical Research, Inc.
Miami, Florida, United States, 33135
Suncoast Research
Miami, Florida, United States, 33176
Medical Health Center & Research
Miami, Florida, United States, 33186
Healthcare Clinical Data Inc
North Miami, Florida, United States, 33161
Sensible Healthcare LLC
Ocoee, Florida, United States, 34761
Bioclinica Research
Orlando, Florida, United States, 32806
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States, 32174
Progressive Medical Research
Port Orange, Florida, United States, 32127
Meridien Research
Saint Petersburg, Florida, United States, 33709
Physician Care Clinical Research, LLC
Sarasota, Florida, United States, 34239-3132
GCP Clinical Research, LLC
Tampa, Florida, United States, 33614
Comprehensive Clinical Development
West Palm Beach, Florida, United States, 33409
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Georgia Research for Women
Atlanta, Georgia, United States, 30312-1220
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
iResearch Atlanta LLC
Decatur, Georgia, United States, 30030
WR-Mount Vernon Clinical Research
Sandy Springs, Georgia, United States, 30328
Georgia Clinical Research
Snellville, Georgia, United States, 30078
United States, Idaho
Elite Clinical Trials
Blackfoot, Idaho, United States, 83221
ASR, LLC-Advanced Specialty Research
Nampa, Idaho, United States, 83687
United States, Illinois
Affinity Clinical Research Institute
Oak Brook, Illinois, United States, 60523
United States, Kansas
Cypress Medical Research Center
Wichita, Kansas, United States, 67226
United States, Louisiana
Praetorian Pharmaceutical Research
Marrero, Louisiana, United States, 70072
Southern Clinical Research Associates
Metairie, Louisiana, United States, 70001
Women Under Study, LLC
New Orleans, Louisiana, United States, 70125
United States, Maryland
Pharmasite Research Inc
Baltimore, Maryland, United States, 21210
United States, Nevada
Clinical Research Center of Nevada (CRCN)
Las Vegas, Nevada, United States, 89104-3218
Dr.R. Garn Mabey, MD,Office Of
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Hassman Research Institute, LLC
Berlin, New Jersey, United States, 08009
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
Bosque Women's Care
Albuquerque, New Mexico, United States, 87109-4640
United States, New York
Circuit Clinical
West Seneca, New York, United States, 14224
United States, North Carolina
Premier Gynecology & Wellness
Charlotte, North Carolina, United States, 28207
Medication Management, LLC
Greensboro, North Carolina, United States, 27408
United States, Ohio
Hwc Women's Research Center
Englewood, Ohio, United States, 45322
United States, Pennsylvania
OB/GYN Associates of Erie
Erie, Pennsylvania, United States, 16507
Dr. Marvin Kalafer MD, Office Of
Jenkintown, Pennsylvania, United States, 19046
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States, 15243
United States, Tennessee
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
United States, Texas
The Clinical Research Center, LLC
Carrollton, Texas, United States, 75007
Advances in Health
Houston, Texas, United States, 77030
Centex Studies, Inc.
Houston, Texas, United States, 77058
FMC Science
Lampasas, Texas, United States, 76550
ClinRx Research
Plano, Texas, United States, 75024
United States, Utah
Granger Medical Clinic
Riverton, Utah, United States, 84065
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States, 84107
United States, Washington
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States, 98115
North Spokane Women's Health
Spokane, Washington, United States, 99207
Canada, Ontario
Site CA15006
Sarnia, Ontario, Canada, N7T 4X3
Site CA15009
Toronto, Ontario, Canada, M3J 2C5
Canada, Quebec
Site CA15007
Levis, Quebec, Canada
Site CA15002
Sherbrooke, Quebec, Canada, J1L 0H8
Site CA15001
Victoriaville, Quebec, Canada, G6P 6P6
Canada
Site CA15008
Quebec, Canada
Czechia
Site CZ42007
Pisek, Czechia, 39701
Site CZ42006
Praha 2, Czechia, 12000
Site CZ42004
Praha 9, Czechia, 190 12
Site CZ42005
Tabor 3, Czechia, 39003
Site CZ42003
Vsetin, Czechia, 75501
Latvia
Site LV37101
Riga, Latvia, 1005
Site LV37103
Riga, Latvia
Poland
Site PL48001
Bydgoszcz, Poland, 85-065
Site PL48013
Elblag, Poland, 82-300
Site PL48009
Katowice, Poland, 40-851
Site PL48011
Krakow, Poland
Site PL48002
Lublin, Poland, 20-069
Site PL48012
Lublin, Poland
Site PL48004
Piaseczno, Poland, 05-500
Site PL48006
Poznan, Poland, 60-192
Site PL48005
Szczecin, Poland, 71-434
Site PL48010
Warsaw, Poland, 02-201
Site PL48003
Warszawa, Poland, 02777
Spain
Site ES34003
Aravaca, Spain, 28023
Site ES34002
Centelles, Spain, 08540
Site ES34001
Madrid, Spain, 28041
United Kingdom
Site GB44001
Shipley, United Kingdom, BD18 3SA
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT04003142    
Other Study ID Numbers: 2693-CL-0302
2018-003529-27 ( EudraCT Number )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
ESN364
menopause
fezolinetant
vasomotor symptoms
Additional relevant MeSH terms:
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Hot Flashes