AzTrials
AzTrials

Hot FlashesPhase 3Skylight 4NCT04003389

A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause

A Phase 3 study testing fezolinetant in people with Hot Flashes, run by Astellas Pharma Global Development, Inc. at 182 sites in 8 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 was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks). Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Hot Flashes
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
1,831 participants
Where
182 sitesin 8 countries
Study dates
10 Jul 2019to 4 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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 > 40 IU/L), or
  • Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
  • Subject is seeking treatment for relief for VMS associated with menopause.
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  • 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 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 mammogram findings (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). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit.
  • Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT) or the ED visit for subjects who are withdrawn from the study prior to completion, and any time during the study in the case of uterine bleeding. 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.

Who cannot join

  • Subject uses a prohibited therapy (strong or moderate cytochrome P450 [CYP] 1A2 inhibitors, hormone replacement therapy [HRT], hormonal contraceptive, any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue such drugs for the full extent of the study.
  • Subject has a 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).
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  • Subject has a 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 x 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.
  • 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 questions 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, as assessed at screening and at the time of visit 2 (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 a partial or full hysterectomy.

Trial locations and contacts

182 sites in 8 countries.

182 sites in 8 countries

United States142 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109-4640

  • SEC Clinical Research

    Andalusia, Alabama, 36420

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Tekton Research - Georgetown

    Austin, Texas, 78745

  • Pharmasite Research Inc

    Baltimore, Maryland, 21208

  • Gadolin Research, LLC

    Beaumont, Texas, 77702

  • Hassman Research Institute, LLC

    Berlin, New Jersey, 08009

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35205

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Investigators Research Group, Llc

    Brownsburg, Indiana, 46254

  • DiscoveResarch, Inc.

    Bryan, Texas, 77802

  • Hope Research Institute

    Canoga Park, California, 91303

  • Alliance Research Inc

    Canoga Park, California, 91304

  • Womens Health USA, Inc.

    Champaign, Illinois, 61820

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28277

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Chattanooga GYN-Oncology

    Chattanooga, Tennessee, 37404

  • WR Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • CTI

    Cincinnati, Ohio, 45227

  • Greater Cincinnati OB/GYN

    Cincinnati, Ohio, 45267

  • Olympian Clinical Research

    Clearwater, Florida, 33757

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213

  • Complete Healthcare For Women

    Columbus, Ohio, 43231

  • Precision Clinical Research

    Coral Springs, Florida, 33065

  • Avant Research Associates, LLC

    Crowley, Louisiana, 70526

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • iResearch Atlanta LLC

    Decatur, Georgia, 30030

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Downtown Women's Health Care

    Denver, Colorado, 80209

  • Horizons Clincial Research Center LLC

    Denver, Colorado, 80220

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • NuDirections Clinical Research

    Duluth, Georgia, 30096

  • Carolina women's research and wellness center

    Durham, North Carolina, 27714

  • Hwc Women's Research Center

    Englewood, Ohio, 45322

  • Achieve Clinical Research, LLC

    Ensley, Alabama, 35218

  • OB-GYN Associates

    Erie, Pennsylvania, 16507

  • MediSphere Medical Research

    Evansville, Indiana, 47714

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Carolina Insitute for Clinical Research

    Fayetteville, North Carolina, 28304

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • Florida Medical Research

    Gainesville, Florida, 32607

  • Unified Women's Clinical Research

    Greensboro, North Carolina, 27408

  • Vital Pharma Research Inc.

    Hialeah, Florida, 33016

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28601

  • Advances in Health

    Houston, Texas, 77030

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Protenium Clinical Research, LLC

    Hurst, Texas, 76054

  • Rosemark Women Care Specialists

    Idaho Falls, Idaho, 83404

  • The Healing Sanctuary, LLC

    Idaho Falls, Idaho, 83404

  • The Clinical Trial Center LLC

    Jenkintown, Pennsylvania, 19046

  • Health Awareness

    Jupiter, Florida, 33458

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055

  • Altus Research

    Lake Worth, Florida, 33461

  • FMC Science

    Lampasas, Texas, 76550

  • Clinical Research Center of Nevada (CRCN)

    Las Vegas, Nevada, 89104-3218

  • Excel Clinical Research, LLC

    Las Vegas, Nevada, 89109

  • Office Of Edmond Pack, Md

    Las Vegas, Nevada, 89113

  • Dr.R. Garn Mabey, MD,Office Of

    Las Vegas, Nevada, 89128

  • Lawrence OBGYN Associates

    Lawrenceville, New Jersey, 08648

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

  • National Research Institute - Panorama

    Los Angeles, California, 90057

  • Praetorian Pharmaceutical Research

    Marrero, Louisiana, 70072

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Medical Research Center of Memphis, LLC

    Memphis, Tennessee, 38120

  • Mesa Obstetricians and Gynecologists

    Mesa, Arizona, 85209

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001

  • Medpharmics, LLC

    Metairie, Louisiana, 70006

  • LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • Medical Research Center of Miami II

    Miami, Florida, 33134

  • Medical Research Centers of South Florida, Inc.

    Miami, Florida, 33144

  • Florida International Research Center

    Miami, Florida, 33174

  • Spotlight research center

    Miami, Florida, 33176

  • Med Research Of Florida, LLC

    Miami, Florida, 33186

  • New Age Medical Research Corporation

    Miami, Florida, 33186

  • Montana Medical Research Inc

    Missoula, Montana, 59801

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • International Clinical Research

    Murfreesboro, Tennessee, 37130

  • EPIC Medical Research

    Murray, Utah, 84123

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Health Research of Hampton Roads Inc

    Newport News, Virginia, 23606

  • Neuro-Behavioral Clinical Research, Inc

    North Canton, Ohio, 44720

  • Healthcare Clinical Data Inc

    North Miami, Florida, 33161

  • Affinity Clinical Research Institute

    Oak Brook, Illinois, 60523

  • Excell Research

    Oceanside, California, 92056

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114

  • Bioclinica Research

    Orlando, Florida, 32806

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32806

  • Omega Research Consultants

    Orlando, Florida, 32808

  • Cornerstone Research Institute

    Orlando, Florida, 32822

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida, 32174

  • Sunset Point Medical Associates

    Palm Harbor, Florida, 34684

  • Philadelphia Clinical Research, LLC

    Philadelphia, Pennsylvania, 19114

  • Medpharmics LLC

    Phoenix, Arizona, 85015

  • Precision Trials

    Phoenix, Arizona, 85032

  • Radiant Research

    Pinellas Park, Florida, 33781

  • ClinRx Research

    Plano, Texas, 75024

  • St. Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Health Awareness

    Port Saint Lucie, Florida, 34952

  • Unified Women's Clinical Research

    Raleigh, North Carolina, 27607

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Infinite Clinical Trials

    Riverdale, Georgia, 30274

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Clinical Trials Research

    Sacramento, California, 95821

  • Northern California Research

    Sacramento, California, 95821

  • Saginaw Valley Medical Research Group, Llc

    Saginaw, Michigan, 48604

  • Advanced Clinical Research-Old Farm OB/GYN (Utah)

    Salt Lake City, Utah, 84107

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Wake Research Associates, LLC

    San Diego, California, 92108

  • Women's Healthcare Affiliates

    San Diego, California, 92111

  • WR-Mount Vernon Clinical Research

    Sandy Springs, Georgia, 30328

  • CITrials, Inc

    Santa Ana, California, 92705

  • Northeast Clinical Research Centers, Inc.

    Schertz, Texas, 78154

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98115

  • Frontier Clinical Research

    Smithfield, Pennsylvania, 15478

  • Georgia Clinical Research

    Snellville, Georgia, 30078

  • Excel Clinical Research, LLC

    Sugar Land, Texas, 77478

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • GCP Clinical Research, LLC

    Tampa, Florida, 33614

  • Premier Medical Associates

    The Villages, Florida, 32159

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360

  • Del Sol Research Management

    Tucson, Arizona, 85712

  • Visions Clinical Research - Tuscon

    Tucson, Arizona, 85712

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Women's Medical Group of Upland

    Upland, California, 91786

  • Bayview Research Group

    Valley Village, California, 91607

  • Tidewater Clinical Research, Inc.

    Virginia Beach, Virginia, 23456

  • Emerson Clinical Research institute

    Washington D.C., District of Columbia, 20011

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472

  • Circuit Clinical

    West Seneca, New York, 14224

  • Cypress Medical Research Center

    Wichita, Kansas, 67226

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

  • Unified Women's Clinical Research

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

Poland11 sites

  • Site PL48004

    Bialystok, 15-224

  • Site PL48005

    Bydgoszcz, 85-065

  • Site PL48002

    Katowice, 40-611

  • Site PL48019

    Katowice, 40-851

  • Site PL48006

    Lublin, 20-069

  • Site PL48014

    Lublin, 20362

  • Site PL48016

    Poznan, 60-192

  • Site PL48010

    Szczecin, 71-434

  • Site PL48020

    Warsaw, 02-201

  • Site PL48003

    Warsaw, 02-798

  • Site PL48007

    Warsaw, 02777

Other trials in Poland

Canada10 sites

  • Site CA15005

    Brampton, Ontario, L6T 0G1

  • Site CA15006

    Burlington, Ontario, L7M 4Y1

  • Site CA15012

    Lévis, Quebec

  • Site CA15004

    Point Claire, Quebec, H9R 4S3

  • Site CA15002

    Québec, Quebec, G1N 4V3

  • Site CA15009

    Québec, Quebec, G1W 4R4

  • Site CA15010

    Sarnia, Ontario, N7T 4X3

  • Site CA15003

    Sherbrooke, Quebec, J1L 0H8

  • Site CA15007

    Toronto, Ontario, M9W 4L6

  • Site CA15001

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

United Kingdom7 sites

  • Site GB44005

    Corby, Northamptonshire, NN17 2UR

  • Site GB44004

    Kenilworth, Warwickshire, CV8 1JD

  • Site GB44006

    Middlesex, HA6 2RN

  • Site GB44007

    Romford

  • Site GB44001

    Shipley, BD18 3SA

  • Site GB44008

    Sidcup, Kent, DA146LT

  • Site GB44003

    Wokingham, Berkshire, RG40 1XS

Other trials in United Kingdom

Czechia6 sites

  • Site CZ42001

    Olomouc, 772 00

  • Site CZ42003

    Olomouc, 779 00

  • Site CZ42010

    Písek, 39701

  • Site CZ42009

    Prague, 12000

  • Site CZ42005

    Tábor, 39003

  • Site CZ42008

    Vodňany, South Bohemian Region, 389 01

Other trials in Czechia

Latvia2 sites

  • Site LV37102

    Riga, 1005

  • Site LV37101

    Riga, 1010

Other trials in Latvia

Spain2 sites

  • Site ES34005

    Centelles, 08540

  • Site ES34002

    Madrid, 28041

Other trials in Spain

Ukraine2 sites

  • Site UA38006

    Kiev

  • Site UA38004

    Zaporizhzhya, Zaporizhzhia Oblast, 69065

Other trials in Ukraine

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

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

The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks). To do that, the study looked at the number and severity of the "adverse events." Those were the side effects that study participants had while they were in the study.

Read more

The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo was a dummy treatment that looked like medicine but did not have any medicine in it.) Women in this study were picked for 1 of the 3 study treatments by chance alone. The study participants took study treatment for 52 weeks.

This study was "double-blinded." That means that the study participants and the study doctors did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo).

At weeks 2 and 4 and then once a month, the study participants went to the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine were collected for laboratory tests. At some study visits, study participants completed questionnaires that were about their quality of life. At the first and last study visits, they had a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA created pictures of the inside of these areas with low-dose x-rays. (The dose was approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still had their uterus had 2 more tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involved removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test was transvaginal ultrasound. It used sound waves to create pictures of the organs in the pelvis. The sound waves were transmitted by a probe (transducer), which was placed inside the vagina. Study participants might have had 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 had this test done in the last 12 months had it done at the first study visit. They had done at the last study visit if they were due for their screening mammogram and their own doctor agreed.

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

Read the detailed description

This study consisted of a screening period and a 52 week treatment period. Safety follow up occurred 3 weeks after the last dose of study drug.

Conditions
Hot Flashes
Being tested
fezolinetant, placebo
Keywords
menopause, fezolinetant, ESN364, vasomotor symptoms
Medical subject headings
Hot Flashes

What participants receive

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

  • fezolinetantDrug

    administered orally

  • placeboDrug

    administered orally

Study groups in NCT04003389
Study groupRoleWhat they receive
Fezolinetant 30 mgExperimentalParticipants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, once daily (QD) for a period of 52 Weeks.
Receives: Drug: fezolinetant
Fezolinetant 45 mgExperimentalParticipants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
Receives: Drug: fezolinetant
PlaceboPlacebo comparatorParticipants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a of period of 52 Weeks.
Receives: Drug: placebo

What is being measured

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

  1. 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 therefore be any unfavorable \& unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether or not considered related to MP. An AE is considered "serious" if it results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. A TEAE is defined as an AE observed after starting administration of study drug \& 21 days after the last dose of study drug.

    Measured: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)

  2. Number of Participants With Mild, Moderate and Severe TEAE

    An adverse event (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. A TEAE is defined as an AE observed after starting administration of the study drug and 21 days after the last dose of study drug. Severity of AE we were classified as Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; and Severe: Inability to perform daily activities.

    Measured: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)

  3. Percentage of Participants With Endometrial Hyperplasia

    Endometrial hyperplasia was confirmed from the endometrial biopsy report.

    Measured: Baseline Up to 52 weeks

  4. Percentage of Participants With Endometrial Cancer

    Endometrial cancer was confirmed from the endometrial biopsy report.

    Measured: Baseline Up to 52 weeks

Secondary outcomes (8)

  1. Change From Baseline in Endometrial Thickness at Week 52

    Endometrial thicness was obtained from the transvaginal ultrasound. The endometrium was measured in the long axis or sagittal plane. The measurement was of the thickest echogenic area from 1 basal endometrial interface across the endometrial canal to the other basal surface.

    Measured: Baseline and week 52

  2. Percentage of Participants With Disordered Proliferative Endometrium

    Disordered proliferative endometrium was confirmed from the endometrial biopsy report.

    Measured: Baseline Up to 52 weeks

  3. Change From Baseline in Bone Mineral Density (BMD) at Hip at Week 52

    Changes in BMD hip was assessed by dual-energy X-ray absorptiometry (DXA) scan.

    Measured: Baseline and week 52

  4. Change From Baseline in Trabecular Bone Score (TBS) at Hip at Week 52

    TBS was a bone texture assessment that serves as a substitute for bone microarchitecture and predicts fracture risk independent of BMD and clinical risk factors. The DXA imaging was processed and analyzed as it would normally be and then evaluated using an automated algorithm to determine the TBS. T-score ≥1.350 was considered to be normal; T-score between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and T-score ≤1.200 defines degraded microarchitecture.

    Measured: Baseline and week 52

  5. Change From Baseline in BMD at Spine at Week 52

    Changes in BMD spine was assessed by DXA scan.

    Measured: Baseline and week 52

  6. Change From Baseline in TBS at Spine at Week 52

    TBS was a bone texture assessment that serves as a substitute for bone microarchitecture and predicts fracture risk independent of BMD and clinical risk factors. The DXA imaging was processed and analyzed as it would normally be and then evaluated using an automated algorithm to determine the TBS. T-score ≥1.350 was considered to be normal; T-score between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and T-score ≤1.200 defines degraded microarchitecture.

    Measured: Baseline and week 52

  7. Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS assessed the risk for suicidal behavior and suicide ideation. Participants responded as "Yes" or "No" 10 items. Suicidal ideation (1. Wish to be dead; 2. Non-specific active suicidal thoughts; 3. Active suicidal ideation with any methods (not plan) without intent to act; 4. Active suicidal ideation with some intent to act, without specific plan; 5. Active suicidal ideation with specific plan and intent; ). Suicidal behaviour (1. Preparatory acts or behavior 2. Aborted attempt 3. Interrupted attempt 4. Actual attempt 5. Completed suicide). Participants with 'Yes' to any one of the above 10 questions for suicidal ideation and behavior were reported.

    Measured: Baseline, week 12, week 24, week 52 and follow-up (week 55)

  8. Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS

    The C-SSRS assessed the risk for Self-injurious Behavior without Suicidal Intent. Question was asked "Has participant engaged in Non-Suicidal Self-Injurious Behavior?". Participants with 'yes' to the question were reported.

    Measured: Baseline, week 12, week 24, week 52 and follow-up (week 55)

Timeline

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

  1. First posted1 Jul 2019
  2. Study start10 Jul 2019
  3. Primary completion4 Jan 2022
  4. Study completion4 Jan 2022

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
1,831 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04003389
Sponsor's protocol ID
2693-CL-0304
Other IDs
2019-000275-16, 2019
Acronym
Skylight 4
Status last verified
Oct 2024
First submitted
27 Jun 2019
Last updated
5 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
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

  • Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, Ottery FD. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147-1164. doi: 10.1007/s12325-024-03073-8. Epub 2024 Dec 30.

    PubMed 39739195

  • Neal-Perry G, Cano A, Lederman S, Nappi RE, Santoro N, Wolfman W, English M, Franklin C, Valluri U, Ottery FD. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):737-747. doi: 10.1097/AOG.0000000000005114. Epub 2023 Mar 9.

    PubMed 36897180

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fezolinetant in people with Hot Flashes, run by Astellas Pharma Global Development, Inc. at 182 sites in 8 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 14 inclusion and 20 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Poland, Canada, United Kingdom, Czechia and 3 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?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)). The study lists 4 primary outcomes in all. 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 NCT04003389, which also lists 2 linked publications.

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 5 Nov 2024.

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