A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
Skylight 1
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
2 other identifiers
interventional
527
7 countries
96
Brief Summary
This study was 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 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 looks like medicine but did not had any medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing. The study evaluated if fezolinetant reduces the number of hot flashes. And the study evaluated if fezolinetant reduces the severity of the hot flashes. Women in the study received an electronic handheld device at the first study visit. (It was similar to a smart phone.) Each day of the study, study participants used this to record their hot flashes. Their record for the 10 days before the start of study treatment was checked. They remained in the study if their record shown 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It was like flipping a coin. The study participants took 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 did not knew who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors knew which study treatment that study participant took during that time. Women who took fezolinetant during the first 12 weeks continued to take the same dose. Women who took placebo during the first 12 weeks took fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants visited 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 was collected for laboratory tests. Study participants completed questionnaires that were about how hot flashes affect their daily life. Study participants who still had their uterus had the following 2 tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test is transvaginal ultrasound. This test 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 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 had this test done in the last 12 months had it done at the first study visit. They had 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 was 3 weeks after the last dose of study treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedStudy Start
First participant enrolled
July 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2021
CompletedResults Posted
Study results publicly available
August 12, 2022
CompletedNovember 4, 2024
October 1, 2024
1.3 years
June 27, 2019
July 13, 2022
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but participant was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Baseline and week 4
Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but participant was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.
Baseline and week 12
Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4
Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but participant was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.
Baseline and week 4
Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12
Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but participant was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no mild or moderate or severe VMS. Higher scores indicates greater severity.
Baseline and week 12
Secondary Outcomes (10)
Change From Baseline in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) Total Score at Week 12
Baseline and week 12
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12
Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12
Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12
Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12
Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
- +5 more secondary outcomes
Study Arms (5)
Double-blind Period: Placebo
PLACEBO COMPARATORParticipants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg
EXPERIMENTALParticipants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg
EXPERIMENTALParticipants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg orally, QD from week 13 up to Week 52 during extension treatment period.
Double-blind Period: Placebo /Extension Period: Fezolinetant 30 mg
EXPERIMENTALParticipants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
Double-blind Period: Placebo /Extension Period: Fezolinetant 45 mg
EXPERIMENTALParticipants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Interventions
Oral Tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
SEC Clinical Research
Andalusia, Alabama, 36420, United States
Central Research Associates
Birmingham, Alabama, 59405, United States
Achieve Clinical Research, LLC
Ensley, Alabama, 35218, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
Eclipse Clinical Research
Tucson, Arizona, 85745, United States
Advanced Clinical Research - Rancho Paseo
Banning, California, 92220, United States
Hope Clinical Research, LLC
Canoga Park, California, 91303, United States
Alliance Research Inc
Canoga Park, California, 91304, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
National Research Institute - Panorama
Los Angeles, California, 90057, United States
Northern California Research
Sacramento, California, 95821, United States
Precision Research Institute, Inc
San Diego, California, 92114, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20011, United States
Precision Clinical Research
Coral Springs, Florida, 33065, United States
American Research Institute, Inc.
Cutler Bay, Florida, 33157, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Clinical Physiology Associates
Fort Myers, Florida, 33912, United States
Vital Pharma Research Inc.
Hialeah, Florida, 33016, United States
Health Awareness
Jupiter, Florida, 33458, United States
GYN Research Center
Kissimmee, Florida, 34741, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Altus Research
Lake Worth, Florida, 33461, United States
Medical Research Center of Miami II
Miami, Florida, 33134, United States
Spotlight research center
Miami, Florida, 33176, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32806, United States
Cornerstone Research Institute
Orlando, Florida, 32822, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, 32081, United States
Health Awareness
Port Saint Lucie, Florida, 34952, United States
International Clinical Research
Sanford, Florida, 32771, United States
Premier Medical Associates
The Villages, Florida, 32159, United States
Better Health Greater Life
Atlanta, Georgia, 30312, United States
Gwinnett Research Institute
Buford, Georgia, 30519, United States
IACT Health
Columbus, Georgia, 31904, United States
NuDirections Clinical Research
Duluth, Georgia, 30096, United States
Infinite Clinical Trials
Riverdale, Georgia, 30274, United States
The Healing Sanctuary, LLC
Idaho Falls, Idaho, 83404, United States
Avant Research Associates, LLC
Crowley, Louisiana, 70526, United States
Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Saginaw Valley Medical Research Group, Llc
Saginaw, Michigan, 48604, United States
Montana Medical Research Inc
Missoula, Montana, 59801, United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109, United States
Office Of Edmond Pack, Md
Las Vegas, Nevada, 89113, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Unified Women's Clinical Research
Greensboro, North Carolina, 27408, United States
Unified Womens Clinical Research
Raleigh, North Carolina, 27607, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
Complete Healthcare For Women
Columbus, Ohio, 43231, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, 44720, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29406, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Invocare Clinical Research Center
West Columbia, South Carolina, 29169, United States
Medical Research Center of Memphis LLC
Memphis, Tennessee, 38120, United States
International Clinical Research
Murfreesboro, Tennessee, 37130, United States
Accent Clinical Research Professionals
Allen, Texas, 75013, United States
DiscoveResarch, Inc.
Bryan, Texas, 77802, United States
Protenium Clinical Research, LLC
Hurst, Texas, 76054, United States
EPIC Medical Research
Murray, Utah, 84123, United States
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, 23456, United States
Site CA15003
Brampton, Ontario, L6T 0G1, Canada
Site CA15002
Point Claire, Quebec, H9R 4S3, Canada
Site CA15001
Québec, Quebec, G1N 4V3, Canada
Site CA15004
Québec, Quebec, G1W 4R4, Canada
Site CA15006
Québec, Quebec, G3K 2P8, Canada
Site CZ42003
Vodňany, Jihočeský kraj, 389 01, Czechia
Site CZ42001
Olomouc, 772 00, Czechia
Site HU36004
Debrecen, 4024, Hungary
Site HU36001
Kecskemét, 6000, Hungary
Site HU36002
Szekesfeherver, 8000, Hungary
Site PL48012
Katowice, Silesian Voivodeship, 40-648, Poland
Site PL48003
Bialystok, 15-224, Poland
Site PL48013
Katowice, 40-301, Poland
Site PL48004
Katowice, 40-611, Poland
Site PL48007
Lublin, 20362, Poland
Site PL48005
Poznan, 60-848, Poland
Site PL48014
Świdnik, 21040, Poland
Site PL48009
Warsaw, 02-679, Poland
Site PL48001
Warsaw, 02-798, Poland
Site ES34004
Seville, 41018, Spain
Site GB44001
Wokingham, Berkshire, RG40 1XS, United Kingdom
Site GB44003
Orpington, Kent, BR5 3QG, United Kingdom
Site GB44002
Coventry, Warwickshire, CV3 4FJ, United Kingdom
Site GB44004
Middlesex, HA6 2RN, United Kingdom
Related Publications (8)
Shapiro C M M, Neal-Perry G, Stute P, Thurston RC, Wolfman W, English M, Wu X, Ottery FD. Early onset, maintenance of effect, and day-/night-time findings following fezolinetant treatment for moderate to severe vasomotor symptoms associated with menopause: A pooled phase 3 analysis. Maturitas. 2025 Dec;203:108740. doi: 10.1016/j.maturitas.2025.108740. Epub 2025 Oct 6.
PMID: 41259888DERIVEDSantoro N, Neal-Perry G, Stute P, Blogg M, Mancuso S, Morga A, Ottery FD, Siddiqui E. Fezolinetant effect on vasomotor symptoms due to menopause in women unsuitable for hormone therapy. Curr Med Res Opin. 2025 Feb;41(2):375-384. doi: 10.1080/03007995.2025.2470752. Epub 2025 Mar 5.
PMID: 40044127DERIVEDKagan 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.
PMID: 39739195DERIVEDMorga A, Zimmermann L, Valluri U, Siddiqui E, McLeod L, Bender RH. Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data. Adv Ther. 2024 Jul;41(7):2845-2858. doi: 10.1007/s12325-024-02849-2. Epub 2024 May 22.
PMID: 38775925DERIVEDSchultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause. Adv Ther. 2024 Jun;41(6):2233-2252. doi: 10.1007/s12325-024-02787-z. Epub 2024 Feb 24.
PMID: 38396203DERIVEDSchultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric evaluation of the PROMIS SD-SF-8b instrument in individuals experiencing vasomotor symptoms due to menopause. Health Qual Life Outcomes. 2023 Nov 21;21(1):126. doi: 10.1186/s12955-023-02206-x.
PMID: 37990323DERIVEDO'Malley PA. A Nonhormonal Selective NK3R Antagonist for Moderate to Severe Vasomotor Symptoms in Menopause. Clin Nurse Spec. 2023 Nov-Dec 01;37(6):259-261. doi: 10.1097/NUR.0000000000000774. No abstract available.
PMID: 37870510DERIVEDLederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, Thurston RC, English M, Franklin C, Lee M, Neal-Perry G. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091-1102. doi: 10.1016/S0140-6736(23)00085-5. Epub 2023 Mar 13.
PMID: 36924778DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Global Development, Inc
Study Officials
- STUDY DIRECTOR
Executive Medical Director
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 1, 2019
Study Start
July 11, 2019
Primary Completion
October 29, 2020
Study Completion
August 11, 2021
Last Updated
November 4, 2024
Results First Posted
August 12, 2022
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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/.