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Hot FlashesPhase 3Moonlight 3NCT04451226

A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause

A Phase 3 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma China, Inc. at 29 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is for women in menopause with 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 purpose of this study is to find out how safe it is for these women to take fezolinetant 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?
No, everyone receives an active treatment
How many people
150 participants
Where
29 sitesChina
Study dates
30 Jul 2020to 13 Jun 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

  • Subject has a body mass index ≥ 16 kg/m^2 and ≤ 38 kg/m^2 at the screening visit.
  • Subject confirmed as menopausal per 1 of the following criteria at the screening visit:
  • O Subject has spontaneous amenorrhea for >= 12 consecutive months O Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] > 40 International Units per Liter [IU/L], or O Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit (with or without hysterectomy).
  • O FSH > 40 IU/L if subjects received hysterectomy but still have ovary
  • Subject is seeking treatment for relief for VMS associated with menopause.
  • 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.
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  • Subject has documentation of a normal/negative or no clinically significant abnormal findings on mammogram (or echo) (e.g., <BI-RADS class 4; obtained at screening or within the prior 12 months of screening). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant abnormal 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). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit. This is not required for subjects who have had a partial (supra-cervical) or full hysterectomy.
  • Subject is willing to undergo an endometrial biopsy at screening and at week 52 (end of treatment) or the ED visit if endometrial thickness > 4 millimeter (mm) indicated by TVU; and subject is willing to undergo an endometrial biopsy at any time during the study in the case of uterine bleeding. This is not required for subjects who have had a partial (supra-cervical) 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.
  • Subject has documentation of a normal or not clinically significant abnormal Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months of screening or at screening. This is not required for subjects who have had a full hysterectomy.
  • Subject has a negative urine pregnancy test at screening.
  • Subject has a negative serology panel (including hepatitis B virus surface antigen [HBs] and hepatitis C virus antibody [anti-HCV], and human immunodeficiency virus [HIV]) 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 and 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 a history of a malignant tumor, except for non-metastatic basal cell carcinoma of the skin.
  • Subject has uncontrolled hypertension, defined as systolic blood pressure >= 140 millimeters of mercury (mmHg) or diastolic blood pressure as >= 90 mmHg based on an average of 2 to 3 readings within the screening period.
  • O Subjects with a medical history of hypertension who are well controlled may be enrolled.
  • O Subjects who do not meet the criteria may, be re-assessed after initiation or review of antihypertensive measures.
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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.
  • For subjects with a uterus: 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 abnormal finding.
  • For subjects with an endometrial thickness > 4 mm as indicated by TVU at screening: Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant abnormal findings in the at screening. A biopsy with insufficient material for evaluation, or unevaluable material is acceptable provided the endometrial thickness is no greater than 8 mm.
  • Subject has a history of an undiagnosed uterine bleeding within the last 6 months of screening.
  • 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) at screening. Subject 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. Subject 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. Subject with Gilbert's syndrome with elevated total bilirubin (TBL) may be enrolled as long as hemolysis is ruled out (i.e., direct bilirubin (DBL), 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 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at the screening visit.
  • Subject has a history of suicide attempt or suicidal behavior within the prior to 12 months of study enrollment or has suicidal ideation within the prior to 12 months of study enrollment (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS), or who is at significant risk to commit suicide at screening and at visit 2.
  • Subject has previously been enrolled in a clinical trial with fezolinetant.
  • Subject has received an investigational study drug within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Subject is unable or unwilling to complete the study procedures.
  • Subject has any condition which, makes the subject unsuitable for study participation.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Site CN86002

    Beijing

  • Site CN86015

    Beijing

  • Site CN86029

    Beijing

  • Site CN86032

    Chengdu

  • Site CN86001

    Guangzhou

  • Site CN86019

    Guangzhou

  • Site CN86022

    Guangzhou

  • Site CN86040

    Guangzhou

  • Site CN86042

    Guangzhou

  • Site CN86008

    Hangzhou

  • Site CN86012

    Hangzhou

  • Site CN86005

    Hunan

  • Site CN86039

    Jiangsu

  • Site CN86010

    Jinlin

  • Site CN86020

    Kunming

  • Site CN86037

    Liuzhou

  • Site CN86006

    Nanjing

  • Site CN86007

    Nanjing

  • Site CN86018

    Nanning

  • Site CN86034

    Ningxia Hui Nationality Autonomous Region

  • Site CN86009

    Shanghai

  • Site CN86011

    Shanxi

  • Site CN86004

    Shenzhen

  • Site CN86028

    Shijiazhuang

  • Site CN86026

    Suzhou

  • Site CN86038

    Taiyuan

  • Site CN86030

    Tianjin

  • Site CN86036

    Tianjin

  • Site CN86025

    Wuhan

Other trials in China

About this study

Official title: A Single-Arm Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women in China Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

This study is for women in menopause with 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 purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatment is fezolinetant (1 tablet of fezolinetant) once a day. The study participants will take study treatment for 52 weeks. At weeks 2 and 4 and then once a month, the study participants will go 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. At some study visits, study participants will complete questionnaires that are about their quality of life. Study participants who still have their uterus will have 2 more 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. It 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

The study will consist of a screening period, a 52-week treatment period and a follow-up visit, 3 weeks after the last dose of study drug.

Conditions
Hot Flashes
Being tested
Fezolinetant
Keywords
Vasomotor Symptoms, menopause, fezolinetant, ESN364
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, VEOZAH

    Oral

Study groups in NCT04451226
Study groupRoleWhat they receive
FezolinetantExperimentalParticipants will receive fezolinetant 30 milligrams (mg) orally once daily for 52 weeks.
Receives: Drug: Fezolinetant

What is being measured

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

  1. 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 55 weeks

  2. 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 55 weeks

Secondary outcomes (13)

  1. Change From Baseline in Endometrial Thickness

    Endometrial thickness is a measure of how thick the lining of the uterus is. Change from baseline will be reported.

    Measured: Baseline and 52 weeks

  2. 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. Percentage of participants will be reported.

    Measured: Up to 52 weeks

  3. Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 55 weeks

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

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 55 weeks

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

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for 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) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.

    Measured: Up to 55 weeks

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

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to 52 weeks

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

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

    Measured: Baseline, week 52 and week 55

  8. Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) Levels

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

    Measured: Baseline, week 52 and week 55

  9. Change From Baseline in Carboxy-terminal Telopeptide of Type I Collagen (CTX) Levels

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

    Measured: Baseline, week 52 and week 55

  10. Change From Baseline in Serum Concentration of Sex Hormones

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

    Measured: Baseline, week 4, week 12, week 24 , week 52 and week 55

  11. 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 , week 52 and week 55

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

    Concentration will be recorded from the PK plasma samples collected.

    Measured: Week 4, week 12, week 24 and week 52

  13. 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 24 and week 52

Timeline

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

  1. First posted30 Jun 2020
  2. Study start30 Jul 2020
  3. Primary completion13 Jun 2022
  4. Study completion13 Jun 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451226
Sponsor's protocol ID
2693-CL-0307
Other IDs
CTR20200676
Acronym
Moonlight 3
Status last verified
Jan 2025
First submitted
26 Jun 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

  • Yu Q, Ming F, Ma J, Cai Y, Wang L, Ren M, Zhang J, Ma X, Miyazaki K, He W, Wang X. Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial. J Int Med Res. 2024 May;52(5):3000605241246624. doi: 10.1177/03000605241246624.

    PubMed 38818887

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 29 sites in China.

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 13 inclusion and 19 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 29 sites in China. 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. 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?

Number of Participants With Adverse Events (time frame: Up to 55 weeks). The study lists 2 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 NCT04451226, 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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