Hot FlashesOPTION-VMSNCT06049797
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
An observational study of Hot Flashes, run by Astellas Pharma Global Development, Inc. at 48 sites in United States.
Trial summary
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Fezolinetant, Paroxetine and Citalopram
- Type of treatment
- Pill or oral medicine
- How many people
- 999 participants
- Where
- 48 sitesUnited States
- Study dates
- 15 Nov 2023to 7 May 2026
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants experiencing bothersome VMS with a confirmed diagnosis of VMS by an HCP and newly prescribed non-hormonal therapy (non-HT).
Who may be able to join
- Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
- HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
- Participant's health status is stable based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.
- If participant has been prescribed an SSRI or SNRI for the treatment of depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months prior to screening.
- Participant has a negative urine pregnancy test at screening if not post-menopausal.
- Only for participants utilizing complementary and alternative therapies, mind-body techniques, or supplements for the treatment of VMS: participant has been on such therapies for ≥ 3 months prior to screening and intends to continue through duration of study.
- Confirmation has been made that the participant is able to obtain the prescribed non hormonal therapy (e.g., insurance coverage verified, participant has ability to self pay, or patient support program activated for at least 12 months for the uninsured participants, if applicable).
Who cannot join
- Participant is currently enrolled in any interventional or non-interventional wearable device study.
- Participant has any condition which makes the participant unsuitable for the study.
- Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
- Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
- Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
- Participant is currently pregnant or planning to become pregnant.
Show all 18Show fewer
- Participant is post-menopausal and has a history of unexplained uterine bleeding within the last 6 months.
- Participant has pre-existing uncontrolled thyroid disease.
- Participant has unstable angina or participant has uncontrolled hypertension based on a standard of care assessment.
- Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
- Participants with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
- Participant has had insomnia unrelated to either menopause or bothersome VMS due to/associated with menopause.
- Participant has known substance abuse or alcohol addiction within 6 months of screening.
- Participant has been on intramuscular estradiol within 8 weeks of screening.
- Participant has a current diagnosis of a malignancy or history of a malignancy within the past 2 years (This does not include basal cell carcinoma or breast cancer.)
- Participants with metastatic (Stage 4) breast cancer.
- Participants who have been prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors with or without gonadotropin-releasing hormone analogues) for their non-metastatic (stage 0 to 3) breast cancer but have not maintained a stable treatment regimen for at least 3 months prior to screening.
- Participant has initiated hormone pellet therapy within 6 months of screening.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Bosque Women's Care
Albuquerque, New Mexico, 87109
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30342
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
Aurora, Colorado, 80045
Alabama Clinical Therapeutics
Birmingham, Alabama, 35205
Accel Research Sites-Cahaba Medical Care-OBGYN
Birmingham, Alabama, 35218
Investigators Research Group, Llc
Brownsburg, Indiana, 46112
Premier Gynecology & Wellness
Charlotte, North Carolina, 28207
Chattanooga Medical Research, Llc
Chattanooga, Tennessee, 37404
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607
Accel Research Sites
DeLand, Florida, 32720
Nextlevel Research Center
Doral, Florida, 33172
Alpha Clinical Research Georgia
Dunwoody, Georgia, 30350
HWC Women's Research Center
Englewood, Ohio, 45322
Signature Gyn Services
Fort Worth, Texas, 76104
UT Health Women's Research Center at Memorial City
Houston, Texas, 77024
TMC Life Research, Inc
Houston, Texas, 77054
Biopharma Informatic Research Center
Houston, Texas, 77084
Pioneer Research Solutions, Inc
Houston, Texas, 77099
Clinical Research Prime
Idaho Falls, Idaho, 83404
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC)
Lake City, Florida, 32055
Altus Research
Lake Worth, Florida, 33461
Torrance Clinical Research Institute,Inc
Lomita, California, 90717
Praetorian Pharmaceutical Research
Marrero, Louisiana, 70072
Southern Clinical Research Associates
Metairie, Louisiana, 70001
Suncoast Research Associates, LLC
Miami, Florida, 33173
Dr. Jarrett's Wellness Center
Miami, Florida, 33186
Montana Medical Research, Inc.
Missoula, Montana, 59808
Tekton Research
Moore, Oklahoma, 73160
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Complete Health Research
Ormond Beach, Florida, 32174
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, 19114
Precision Trials AZ, LLC
Phoenix, Arizona, 85032
ClinRx Research LLC
Plano, Texas, 75024
Dream Team Clinical Research
Pomona, California, 91767
Granger Medical Clinic
Riverton, Utah, 84065
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258
Wake Research - Medical Center for Clinical Research WR-MCCR, LLC
San Diego, California, 92120
Seattle Clinical Research Center
Seattle, Washington, 98104
Millennium Clinical Trials LLC
Simi Valley, California, 93065
Bayview Research Group, LLC
Valley Village, California, 91607
Biocentric Health Research
West Columbia, South Carolina, 29169
Comprehensive Clinical Trials, Llc
West Palm Beach, Florida, 33409
Reading Hospital / Tower Health
West Reading, Pennsylvania, 19611
Upstate Clinical Research Associates
Williamsville, New York, 14221
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined.
- Conditions
- Hot Flashes
- Being tested
- Fezolinetant, Paroxetine, Citalopram, Escitalopram, Desvenlafaxine
- Keywords
- fezolinetant, vasomotor symptoms, menopause, night sweats, non-hormonal treatment
- 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
ParoxetineDrug
Oral
CitalopramDrug
Oral
EscitalopramDrug
Oral
DesvenlafaxineDrug
Oral
VenlafaxineDrug
Oral
GabapentinDrug
Oral
ClonidineDrug
Oral
PregabalinDrug
Oral
OxybutyninDrug
Oral
Any other SSRI/SNRI not already specifiedDrug
Oral
Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category aboveDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Neurokinin 3 Receptor (NK3-R) Antagonist | Participants prescribed NK3-R Antagonist for the treatment of VMS. Receives: Drug: Fezolinetant | |
| Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) | Participants prescribed SSRI/SNRI for the treatment of VMS. Receives: Drug: Paroxetine; Drug: Citalopram; Drug: Escitalopram; Drug: Desvenlafaxine; Drug: Venlafaxine; Drug: Any other SSRI/SNRI not already specified | |
| Other | Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS. Receives: Drug: Gabapentin; Drug: Clonidine; Drug: Pregabalin; Drug: Oxybutynin; Drug: Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
Measured: Baseline and week 12
Secondary outcomes (24)
Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain
Participants with a reduction (improvement) in symptom bother score ≥ 1 unit will be classified as 1-point responders.
Measured: Up to week 52
Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain
Participants with a reduction (improvement) in symptom bother score ≥ 2 unit will be classified as 2-point responders.
Measured: Up to week 52
Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b
The PROMIS SD SF 8b assesses self-reported sleep disturbance over the past 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).
Measured: Baseline and weeks 4, 8, 12, 24 and 52
Total score from Patient Global Impression of Severity (PGI-S) of SD
The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems.
Measured: Up to week 52
Total score from Patient Global Impression of Change (PGI-C) of SD
PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Ratings range from (1) much better to (7) much worse.
Measured: Up to week 52
Change from baseline in average daily total sleep time, as recorded by wearable device
The wearable device will capture movement and physiological signals to derive measures related to sleep.
Measured: Baseline to weeks 4, 8 and 12
Change from baseline in average daily sleep efficiency, as recorded by wearable device
The wearable device will capture movement and physiological signals to derive measures related to sleep.
Measured: Baseline to weeks 4, 8 and 12
Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device
The wearable device will capture movement and physiological signals to derive measures related to sleep.
Measured: Baseline to weeks 4, 8 and 12
Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device
The wearable device will capture movement and physiological signals to derive measures related to sleep.
Measured: Baseline to weeks 4, 8 and 12
Change from baseline in average daily sleep latency, as recorded by wearable device
The wearable device will capture movement and physiological signals to derive measures related to sleep.
Measured: Baseline to weeks 4, 8 and 12
Mean change from baseline in the MENQoL total score
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. The total score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
Measured: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
Measured: Baseline to weeks 4, 8, 24 and 52
Mean change from baseline in the MENQoL 1-week recall psychosocial domain score
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
Measured: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the MENQoL 1-week recall physical domain score
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
Measured: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the MENQoL 1-week recall sexual domain score
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
Measured: Baseline to weeks 4, 8, 12, 24 and 52
Total score from PGI-C VMS
PGI-C VMS evaluates participant perceived change in VMS. Ratings range from (1) much better to (7) much worse.
Measured: Up to week 52
Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score
The WPAI-VMS is a 6-item PRO measure that examines VMS-related work productivity and activity in the preceding 7 days. It consists of 4 domains: absenteeism, presenteeism, overall work productivity loss, and activity impairment. WPAI-VMS outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (that is, worse outcomes).
Measured: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the female sexual function index (FSFI) domain score
The FSFI is comprised of 19 questions with response options varying among items and ranging from 0 to 5 or 1 to 5. The FSFI has 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Within the individual domains, a domain score of zero indicates that the participant-reported having no sexual activity during the past month. The overall score can range from 2 to 36. A higher score overall or for individual domains indicates better sexual function.
Measured: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the mean number of moderate/severe VMS episodes per 24 hours self-reported by participants via an an eDiary
Participant manually records moderate/severe VMS episodes on the eDiary.
Measured: Baseline to weeks 4, 8 and 12
Mean change from baseline in the mean number of daytime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary
Participant manually records moderate/severe VMS episodes on the eDiary
Measured: Baseline to weeks 4, 8 and 12
Mean change from baseline in the mean number of nighttime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary
Participant manually records moderate/severe VMS episodes on the eDiary.
Measured: Baseline to weeks 4, 8 and 12
Number of participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product.
Measured: Up to 52 weeks
Number of participants with Serious Adverse Events (SAEs)
An AE is considered "serious" if, in the view of either the investigator or sponsor, it:
Results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly or birth defect of a child conceived during the exposure of one of the parents to the drug studied, requires inpatient hospitalization or leads to prolongation of hospitalization, is a medically important event or reaction.
Measured: Up to 52 weeks
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 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Nov 2023
- Primary completion6 Sep 2025
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049797
- Sponsor's protocol ID
- 2693-MA-3457
- Acronym
- OPTION-VMS
- Status last verified
- May 2026
- First submitted
- 18 Sep 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT06049797
- Acronym / sponsor ID
- OPTION-VMS / 2693-MA-3457
- Conditions
- Hot Flashes
- Keywords
- fezolinetant, vasomotor symptoms, menopause, night sweats, non-hormonal treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 6 Sep 2025 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurokinin 3 Receptor (NK3-R) Antagonist | – | Drug: FezolinetantParticipants prescribed NK3-R Antagonist for the treatment of VMS. |
| Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) | – | Drug: Paroxetine, Drug: Citalopram, Drug: Escitalopram, Drug: Desvenlafaxine, Drug: Venlafaxine, Drug: Any other SSRI/SNRI not already specifiedParticipants prescribed SSRI/SNRI for the treatment of VMS. |
| Other | – | Drug: Gabapentin, Drug: Clonidine, Drug: Pregabalin, Drug: Oxybutynin, Drug: Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category aboveParticipants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants experiencing bothersome VMS with a confirmed diagnosis of VMS by an HCP and newly prescribed non-hormonal therapy (non-HT).
Key inclusion criteria (7 listed)
- Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
- HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
- Participant's health status is stable based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.
- If participant has been prescribed an SSRI or SNRI for the treatment of depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months prior to screening.
- Participant has a negative urine pregnancy test at screening if not post-menopausal.
Key exclusion criteria (18 listed)
- Participant is currently enrolled in any interventional or non-interventional wearable device study.
- Participant has any condition which makes the participant unsuitable for the study.
- Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
- Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
- Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FezolinetantAlso: ESN364, VEOZAHOral | Drug | Neurokinin 3 Receptor (NK3-R) Antagonist |
| ParoxetineOral | Drug | Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) |
| CitalopramOral | Drug | Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) |
| EscitalopramOral | Drug | Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) |
| DesvenlafaxineOral | Drug | Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) |
| VenlafaxineOral | Drug | Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) |
| GabapentinOral | Drug | Other |
| ClonidineOral | Drug | Other |
| PregabalinOral | Drug | Other |
| OxybutyninOral | Drug | Other |
| Any other SSRI/SNRI not already specifiedOral | Drug | Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI) |
| Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category aboveOral | Drug | Other |
Primary outcome
Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score
Time frame: Baseline and week 12
The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL.
24 secondary outcomes
Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain
Time frame: Up to week 52
Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain
Time frame: Up to week 52
Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b
Time frame: Baseline and weeks 4, 8, 12, 24 and 52
Total score from Patient Global Impression of Severity (PGI-S) of SD
Time frame: Up to week 52
Total score from Patient Global Impression of Change (PGI-C) of SD
Time frame: Up to week 52
Change from baseline in average daily total sleep time, as recorded by wearable device
Time frame: Baseline to weeks 4, 8 and 12
Change from baseline in average daily sleep efficiency, as recorded by wearable device
Time frame: Baseline to weeks 4, 8 and 12
Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device
Time frame: Baseline to weeks 4, 8 and 12
Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device
Time frame: Baseline to weeks 4, 8 and 12
Change from baseline in average daily sleep latency, as recorded by wearable device
Time frame: Baseline to weeks 4, 8 and 12
Mean change from baseline in the MENQoL total score
Time frame: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score
Time frame: Baseline to weeks 4, 8, 24 and 52
Mean change from baseline in the MENQoL 1-week recall psychosocial domain score
Time frame: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the MENQoL 1-week recall physical domain score
Time frame: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the MENQoL 1-week recall sexual domain score
Time frame: Baseline to weeks 4, 8, 12, 24 and 52
Total score from PGI-C VMS
Time frame: Up to week 52
Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score
Time frame: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the female sexual function index (FSFI) domain score
Time frame: Baseline to weeks 4, 8, 12, 24 and 52
Mean change from baseline in the mean number of moderate/severe VMS episodes per 24 hours self-reported by participants via an an eDiary
Time frame: Baseline to weeks 4, 8 and 12
Mean change from baseline in the mean number of daytime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary
Time frame: Baseline to weeks 4, 8 and 12
Mean change from baseline in the mean number of nighttime moderate/severe VMS episodes per 24 hours self-reported by participants via an eDiary
Time frame: Baseline to weeks 4, 8 and 12
Number of participants with Adverse Events (AEs)
Time frame: Up to 52 weeks
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 52 weeks
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Global Development, Inc.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hot Flashes, run by Astellas Pharma Global Development, Inc. at 48 sites in United States.
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 7 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 5 Jun 2026. 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 United States. 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.
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 to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.