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Hot FlashesPhase 3Moonlight 1NCT04234204

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause

A Phase 3 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma China, Inc. at 48 sites in 3 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 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 (1 tablet) once a day or placebo (1 tablet) once a day. 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
302 participants
Where
48 sitesin 3 countries
Study dates
17 Mar 2020to 20 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Participant has a body mass index ≥16 kg/m^2 and ≤38 kg/m^2 (extremes included) at screening visit.
  • Participant 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 (with or without hysterectomy)
  • FSH > 40 IU/L if participants received hysterectomy but still have ovary
Show all 15Show fewer
  • Within the 10 days prior to randomization, participant must have a minimum average of 7 to 8 moderate to severe HFs (VMS) per day, or 50 to 60 per week.
  • Participant 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.
  • Participant has documentation of a normal/negative or no clinically significant findings mammogram (or echo) (e.g. < BI-RADS class 4; 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.
  • Participant is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and week 24 (end-of-treatment), and for participants who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit. This is not required for participants who have had a partial (supra-cervical) or full hysterectomy.
  • Participant is willing to undergo an endometrial biopsy at screening, and at week 24 (end of treatment) or early discontinuation (ED) visit if endometrial thickness >4mm indicated by TVU; and participant is willing to undergo an endometrial biopsy at any time during the study in the case of uterine bleeding. This is not required for participants who have had a partial (supracervical) or full hysterectomy. A biopsy with insufficient material for evaluation, or unevaluable material, is acceptable provided the endometrial thickness is no greater than 8 mm.
  • Participant has documentation of a normal or not clinically significant Pap test (or equivalent cervical cytology within the previous 12 months of study enrollment or at screening. This is not required for participants who have had a full hysterectomy.
  • Participant has a negative urine pregnancy test at screening, this is not required for participants who have had a full hysterectomy.
  • Participant has negative serology panel [i.e., negative hepatitis B surface antigen (HBsAg) and negative hepatitis C virus antibody (HCVAb) screens] at screening.
  • Participant agrees not to participate in another interventional study while participating in the present study.

Who cannot join

  • Participant uses a prohibited therapy (strong and 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.
  • Participant has known substance abuse or alcohol addiction within 6 months of screening.
  • Participant has a history of a malignant tumor, except for non-metastatic basal cell carcinoma of the skin.
  • Participant has uncontrolled hypertension, defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure as ≥ 90 mmHg based on an average of 2 to 3 readings within the screening period. Participants with a medical history of hypertension who are well controlled may be enrolled. Participants who do not meet these criteria may, at the discretion of the investigator, be re-assessed after initiation or review of antihypertensive measures.
  • Participant has a history of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients.
  • For Participants with a uterus: Participant 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.
Show all 18Show fewer
  • For Participants with a uterus and endometrial thickness >4mm indicated by TVU: Participant has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant at screening. A biopsy with insufficient material for evaluation, or unevaluable material is acceptable provided the endometrial thickness is no greater than 8 mm.
  • Participant has a history within the last 6 months of undiagnosed uterine bleeding.
  • Participant has a history of seizures or other convulsive disorders.
  • Participant 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.
  • Participant has active liver disease, jaundice, elevated liver aminotransferases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total or direct bilirubin, elevated INR or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to < 1.5 × 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 × 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 hemolysis is ruled out (i.e. direct bilirubin, hemoglobin and reticulocytes are normal).
  • Participant has creatinine > 1.5 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula ≤ 59 mL/min/1.73 m^2 at screening.
  • Participant has a positive result for human immunodeficiency virus (HIV) at screening.
  • Participant 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 visit 2.
  • Participant has previously been enrolled in a clinical trial with fezolinetant.
  • Participant has received investigational study drug within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant is unable or unwilling to complete the study procedures.
  • Participant has any condition which makes the subject unsuitable for study participation.

Trial locations and contacts

48 sites in 3 countries.

48 sites in 3 countries

China31 sites

  • Site CN86001

    Beijing

  • Site CN86002

    Beijing

  • Site CN86017

    Beijing

  • Site CN86030

    Beijing

  • Site CN86022

    Changchun

  • Site CN86009

    Changsha

  • Site CN86037

    Chengdu

  • Site CN86006

    Guangzhou

  • Site CN86019

    Guangzhou

  • Site CN86042

    Guangzhou

  • Site CN86043

    Guangzhou

  • Site CN86018

    Guiyang

  • Site CN86025

    Hangzhou

  • Site CN86034

    Hangzhou

  • Site CN86027

    Kunming

  • Site CN86005

    Liuzhou

  • Site CN86004

    Nanjing

  • Site CN86011

    Nanjing

  • Site CN86035

    Nanjing

  • Site CN86026

    Nanning

  • Site CN86012

    Shanghai

  • Site CN86021

    Shenzhen

  • Site CN86007

    Shijiazhuang

  • Site CN86023

    Taiyuan

  • Site CN86031

    Taiyuan

  • Site CN86015

    Tianjin

  • Site CN86029

    Tianjin

  • Site CN86008

    Wuhan

  • Site CN86041

    Yangzhou

  • Site CN86013

    Yinchuan

  • Site CN86033

    Zhongshan

Other trials in China

South Korea9 sites

  • Site KR82013

    Ansan-si

  • Site KR82005

    Busan

  • Site KR82003

    Seongnam-si

  • Site KR82011

    Seongnam-si

  • Site KR82001

    Seoul

  • Site KR82002

    Seoul

  • Site KR82004

    Seoul

  • Site KR82006

    Seoul

  • Site KR82012

    Seoul

Other trials in South Korea

Taiwan8 sites

  • Site TW88608

    Kaohsiung City

  • Site TW88604

    New Taipei City

  • Site TW88606

    Taichung

  • Site TW88603

    Tainan

  • Site TW88609

    Tainan

  • Site TW88601

    Taipei

  • Site TW88607

    Taipei

  • Site TW88611

    Taipei

Other trials in Taiwan

About this study

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 in Asia Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

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 (1 tablet) once a day or placebo (1 tablet) 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.

Read more

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 24 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 or placebo) during that time. The last 12 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 fezolinetant. Women who take placebo during the first 12 weeks will start taking fezolinetant.

At weeks 2, 4, 8, 12, 14, 16, 20 and 24, 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 if they meet the criteria. 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.

Read the detailed description

This study will consist of a screening period and a 24-week treatment period. Safety follow up will occur 3 weeks after the last dose of study drug.

Conditions
Hot Flashes
Being tested
Fezolinetant, Placebo
Keywords
ESN364, menopause, fezolinetant, 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

    Also called ESN364

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT04234204
Study groupRoleWhat they receive
Fezolinetant groupExperimentalParticipants will receive fezolinetant once daily for 24 weeks.
Receives: Drug: Fezolinetant
Placebo groupPlacebo comparatorParticipants will receive matching placebo for 12 weeks, and then receive fezolinetant for 12 weeks once daily.
Receives: Drug: Fezolinetant; Drug: Placebo

What is being measured

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

  1. Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS)

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

    Measured: Baseline to Week 4

  2. Mean change from baseline in the frequency of moderate to severe VMS

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

    Measured: Baseline to Week 12

  3. Mean change from baseline in the severity of moderate to severe VMS

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

    Measured: Baseline to Week 4

  4. Mean change from baseline in the severity of moderate to severe VMS

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

    Measured: Baseline to Week 12

Secondary outcomes (21)

  1. Mean change from baseline to each week in the frequency of moderate and severe VMS

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

    Measured: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12

  2. Mean change from baseline to each week in the severity of moderate and severe VMS

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

    Measured: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12

  3. Mean percent reduction from baseline to each week in the frequency of moderate and severe VMS

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

    Measured: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12

  4. Percent reduction ≥50% from baseline to each week in the frequency of moderate and severe VMS

    Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Ratio of the participants with ≥50% reduction in frequency will be reported.

    Measured: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12

  5. Percent reduction at 100% from baseline to each week in the frequency of moderate and severe VMS

    Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Ratio of the participants with ≥ 100% reduction in frequency will be reported.

    Measured: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12

  6. Mean change from baseline in the frequency of moderate to severe VMS

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

    Measured: Baseline to Week 24

  7. Mean change from baseline in the severity of moderate to severe VMS

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

    Measured: Baseline to Week 24

  8. Number of Participants With Adverse Events

    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.

    Measured: Up to 27 Weeks

  9. Number of Participants With Adverse Events Based on Severity

    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.

    Measured: Up to 27 Weeks

  10. Change From Baseline in Endometrial Thickness

    Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU).

    Measured: Baseline and Week 24

  11. Percentage of Participants With Endometrial Hyperplasia and/or Endometrial Cancer

    Endometrial hyperplasia is thickening of the lining of the uterus. Endometrial cancer is cancer of the lining of the uterus.

    Measured: Up to 24 Weeks

  12. Number of Participants With Vital Sign Abnormalities and/or Adverse Events

    Number of participants with potentially clinically significant vital sign values will be reported.

    Measured: Up to 27 Weeks

  13. Number of Participants With Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)

    Number of participants with potentially clinically significant ECG values will be reported.

    Measured: Up to 27 Weeks

  14. Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)

    Number of participants with potentially clinically significant laboratory values will be reported.

    Measured: Up to 27 Weeks

  15. Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)

    Change from baseline in serum concentrations of BSAP will be reported.

    Measured: Baseline, Week 24 and Week 27

  16. Change From Baseline in Procollagen Type 1 Aminoterminal Propeptide (P1NP)

    Change from baseline in serum concentrations of P1NP will be reported.

    Measured: Baseline, Week 24 and Week27

  17. Change From Baseline in Carboxy-Terminal Telopeptide of Type I Collagen (CTX)

    Change from baseline in serum concentrations of CTX will be reported.

    Measured: Baseline, Week 24 and Week 27

  18. Pharmacokinetics (PK) of Fezolinetant in Plasma: Concentration

    Concentration will be recorded from the PK plasma samples collected.

    Measured: Week 4, Week 12, Week 16, Week 24

  19. Pharmacokinetics (PK) of Fezolinetant Metabolite ES259564 in Plasma: Concentration

    Concentration will be recorded from the PK plasma samples collected.

    Measured: Week 4, Week 12, Week 16, Week 24

  20. Change from Baseline in Sex Hormones

    Change from baseline in serum concentration of sex hormones will be reported.

    Measured: Baseline, Week 4, Week 12, Week 24 and Week 27

  21. Change from Baseline in Sex Hormone-Binding Globulin (SHBG)

    Change from baseline in serum concentration of SHBG will be reported.

    Measured: Baseline, Week 4, Week 12, Week 24 and Week 27

Timeline

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

  1. First posted21 Jan 2020
  2. Study start17 Mar 2020
  3. Primary completion20 Apr 2022
  4. Study completion20 Apr 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
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04234204
Sponsor's protocol ID
2693-CL-0305
Other IDs
CTR20200360
Acronym
Moonlight 1
Status last verified
Jan 2025
First submitted
16 Jan 2020
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
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 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Ruan X, Bai W, Ren M, Kim T, Lee JY, Chuang FC, Wang PH, He W, Ma X, Miyazaki K, Song N, Wang X, Yu Q. Efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms associated with menopause among women in East Asia: a phase 3 randomized study (MOONLIGHT I). J Int Med Res. 2024 May;52(5):3000605241247684. doi: 10.1177/03000605241247684.

    PubMed 38818888

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 China, Inc. at 48 sites in 3 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 15 inclusion and 18 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China, South Korea, Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS) (time frame: Baseline to Week 4). 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 NCT04234204, which also lists 1 linked publication.

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 31 Jan 2025.

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