AzTrials
AzTrials

Hot FlashesPhase 2StarlightNCT05034042

A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

A Phase 2 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma Inc at 40 sites in Japan.

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 menopausal women who have hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. This study will take place in Japan. 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
147 participants
Where
40 sitesJapan
Study dates
17 Nov 2021to 23 Dec 2022
Phase
Phase 2
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 screening visit.
  • 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:
  • For post-menopausal subjects:
  • 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)
Show all 23Show fewer
  • For peri-menopausal subjects:
  • Skipped menstrual period with amenorrhea for ≥ 60 days but < 6 consecutive months with biochemical criteria of peri-menopause (FSH > 25 IU/L); or
  • Spontaneous amenorrhea for ≥ 6 months but < 12 consecutive months with biochemical criteria of peri-menopause (FSH > 25 IU/L and ≤ 40 IU/L)
  • Within the 10 days prior to randomization, subject must have a minimum average of 7 mild, moderate and severe hot flashes (VMS) per day.
  • Subject is not pregnant and at least 1 of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP)
  • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 21 days after the final study treatment administration
  • Subject must agree not to breastfeed starting at screening and throughout the study period and for 21 days after the final study treatment administration.
  • Subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 21 days after the final study treatment administration.
  • 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 abnormal findings on breast imaging (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 on breast imaging.
  • Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and week 12 (end of treatment), and for subjects who are withdrawn from the study prior to completion, a TVU at the early discontinuation visit. This is not required for subjects who have had a partial (supra-cervical) or full hysterectomy.
  • Subject is willing to undergo 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 and for peri-menopausal subjects in case of menstrual bleeding.
  • Subject has documentation of a normal or not clinically significant abnormal 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 trachelectomy.
  • Subject has a negative urine pregnancy test at screening. Urine pregnancy test is not required for female subjects who are assessed as post-menopausal status.
  • Subject has negative serology panel (i.e. negative hepatitis B surface [HBs] antigen) and negative hepatitis C virus [HCV] antibody) 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 1A2 [CYP1A2] inhibitors, hormone replacement therapy [HRT], hormonal contraceptive or any treatment for VMS [prescription, over the counter, or herbal/Chinese medicine]) or is not willing to wash out and discontinue use of such drugs for the full duration of study conduct or it is not medically appropriate to discontinue such drugs for the duration of the study.
  • Subject has 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.
  • Subject has a history of severe allergy, hypersensitivity, or intolerance to drugs in general, including the IP 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).
Show all 20Show fewer
  • Subject has a history of an undiagnosed uterine bleeding within the previous 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 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 mL/min/1.73 m^2 at screening visit.
  • Subject has a previous positive test for the human immunodeficiency virus.
  • 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 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.
  • Subject has had previous exposure with fezolinetant.
  • Subject has received an IP 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.
  • Subject or relative is the investigator or other site staff directly involved in the conduct of the study.
  • Subject is an employee of the sponsor, contract research organizations (CROs) or site management organizations (SMOs).
  • Present or previous history of participation in a study of the IP.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

Japan40 sites

  • Hamada Hospital

    Chiyoda-ku, Tokyo

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo

  • Ginza Yoshida Clinic

    Chuo-Ku, Tokyo

  • Mori Ladies Clinic

    Fukuoka, Fukuoka

  • SANO Women's Clinic

    Fukuoka, Fukuoka

  • Medical Corp. SEIKOUKAI New Medical Research System Clinic

    Hachioji-shi, Tokyo

  • Unoki Clinic

    Kagoshima, Kagoshima-ken

  • Yoshinaga Women's Clinic

    Kagoshima, Kagoshima-ken

  • Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital

    Kitakyusyu-shi, Fukuoka

  • Kurashiki Medical Clinic

    Kurashiki-shi, Okayama-ken

  • Kurobe City Hospital

    Kurobe-shi, Toyama

  • Omi Medical Center, Social Medical Corporation Seikoukai

    Kusatsu-shi, Shiga

  • Kyoto City Hospital

    Kyoto, Kyoto

  • Juno Vesta Clinic Hatta

    Matsudo-shi, Chiba

  • Social Medical Care Corporation Hosei-kai Marunouchi Hospital

    Matsumoto-shi, Nagano

  • Toranomon Womens Clinic

    Minato-ku, Tokyo

  • Yokokura Clinic

    Minato-ku, Tokyo

  • Shimamura Memorial Hospital

    Nerima-ku, Tokyo

  • Yukawa Women's Clinic

    Nishi-Tokyo-shi, Tokyo

  • Omihachiman Community Medical Center

    Ōmihachiman, Shiga

  • GyNet Medical Corporation Minamimorimachi Ladies' Clinic

    Osaka, Osaka

  • Nomura Clinic Namba

    Osaka, Osaka

  • Sophia Ladies Clinic

    Sagamihara-shi, Kanagawa

  • Maruyama Memorial General Hospital

    Saitama-shi, Saitama

  • Ena Odori Clinic

    Sapporo, Hokkaido

  • Kotoni Ladies Clinic

    Sapporo, Hokkaido

  • M's Ladies Clinic

    Sapporo, Hokkaido

  • Nishikawa Women's Health Clinic

    Sapporo, Hokkaido

  • Sapporo Medical Center, NTT East Corporation

    Sapporo, Hokkaido

  • Tonan Hospital

    Sapporo, Hokkaido

  • Chieko Yukika Lady's Clinic

    Sendai, Miyagi

  • Seijo Kinoshita Hospital

    Setagaya-ku, Tokyo

  • Japan Community Healthcare Organization Tokuyama Central Hospital

    Shunan-shi, Yamaguchi

  • Asahi-Clinic

    Takamatsu, Kagawa-ken

  • jMOG Medical Corporation Tanabe Ladies' Clinic

    Takatsuki-shi, Osaka

  • Ikebukuro Clinic

    Toshima-ku, Tokyo

  • Ikebukuro Metropolitan Clinic

    Toshima-ku, Tokyo

  • Japan Organization of Occupational Health and Safety Toyama Rosai Hospital

    Uozu-shi, Toyama

  • Tawada Ladies Clinic

    Yokohama, Kanagawa

  • Women's Clinic LUNA Yokohama Motomachi

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Select the Optimal Dose(s) of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause in Japan

This study is for menopausal women who have hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. This study will take place in Japan.

This study will provide more information on a potential new treatment, called fezolinetant. The treatments in this study are fezolinetant or a placebo. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to find the best dose of fezolinetant to reduce the number and severity of hot flashes.

Read more

Women that want to take part in the study will be given an electronic handheld device to track their hot flashes. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. Women will be picked for 1 of 3 treatments (lower or higher dose of fezolinetant, or placebo) by chance alone.

Women who take part in the study will take 2 tablets every day for 12 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (lower or higher dose of fezolinetant, or placebo). The women will continue recording information about their hot flashes on the electronic device. They will also use another device to answer questions about how hot flashes affect their daily life.

During the study, the women will visit their study clinic several times for a check-up. This will happen during weeks 2, 4, 8, 12 and 15. At the check-up, they will be asked if they have any medical problems. Other checks will include some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam, an ECG to check their heart rhythm, and their vital signs checked (pulse rate, temperature and blood pressure). At the first visit and in week 15, women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.

The last check-up (at week 15) will be 3 weeks after they take their last tablets of study medicine (lower or higher dose of fezolinetant or placebo).

Conditions
Hot Flashes
Being tested
Fezolinetant, Placebo
Keywords
Vasomotor Symptoms (Hot Flashes) Associated with Menopause, ESN364, fezolinetant
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 NCT05034042
Study groupRoleWhat they receive
Fezolinetant: low dose (15 mg)ExperimentalParticipants will receive low dose of fezolinetant once daily for 12 weeks.
Receives: Drug: Fezolinetant
Fezolinetant: high dose (30 mg)ExperimentalParticipants will receive high dose of fezolinetant once daily for 12 weeks.
Receives: Drug: Fezolinetant
PlaceboPlacebo comparatorParticipants will receive matching placebo once daily for 12 weeks.
Receives: 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 mild, moderate and severe vasomotor symptom (VMS)

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

    Measured: Baseline and Week 8

Secondary outcomes (7)

  1. Mean change from baseline in the frequency of mild, moderate and severe VMS

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

    Measured: Baseline and up to Week 12

  2. Number of participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a subject administered an investigational product (IP), 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 IP whether or not considered related to the IP.

    Measured: Up to Week 15

  3. 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 12

  4. Number of participants with laboratory value abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Week 15

  5. Number of participants with vital sign abnormalities and/or AEs

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Week 15

  6. Number of participants with electrocardiogram (ECG) abnormalities and/or AEs

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to Week 12

  7. 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 Week 15

Timeline

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

  1. First posted5 Sep 2021
  2. Study start17 Nov 2021
  3. Primary completion11 Nov 2022
  4. Study completion23 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05034042
Sponsor's protocol ID
2693-CL-0206
Other IDs
jRCT2031210334
Acronym
Starlight
Status last verified
Oct 2024
First submitted
1 Sep 2021
Last updated
26 Oct 2024
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 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fezolinetant in people with Hot Flashes, run by Astellas Pharma Inc at 40 sites in Japan.

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 23 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 mild, moderate and severe vasomotor symptom (VMS) (time frame: Baseline and Week 8). 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 NCT05034042.

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 26 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in