A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats (OPTION-VMS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Fezolinetant; Drug: Paroxetine; Drug: Citalopram; Drug: Escitalopram; Drug: Desvenlafaxine; Drug: Venlafaxine; Drug: Any other SSRI/SNRI not already specified; 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

• Study Type: Observational
• Enrollment (Actual): 999

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics
    • Birmingham, Alabama, United States, 35218
      • Accel Research Sites-Cahaba Medical Care-OBGYN
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ, LLC
  • California
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute,Inc
    • Pomona, California, United States, 91767
      • Dream Team Clinical Research
    • San Diego, California, United States, 92120
      • Wake Research - Medical Center for Clinical Research WR-MCCR, LLC
    • Simi Valley, California, United States, 93065
      • Millennium Clinical Trials LLC
    • Valley Village, California, United States, 91607
      • Bayview Research Group, LLC
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites
    • Doral, Florida, United States, 33172
      • Nextlevel Research Center
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC)
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates, LLC
    • Miami, Florida, United States, 33186
      • Dr. Jarrett's Wellness Center
    • Ormond Beach, Florida, United States, 32174
      • Complete Health Research
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Agile Clinical Research Trials, LLC
    • Dunwoody, Georgia, United States, 30350
      • Alpha Clinical Research Georgia
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
    • Idaho Falls, Idaho, United States, 83404
      • Rosemark Women Care Specialists
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute Inc.
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Investigators Research Group, Llc
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Praetorian Pharmaceutical Research
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care
  • New York
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Premier Gynecology & Wellness
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research
  • Ohio
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
  • Oklahoma
    • Moore, Oklahoma, United States, 73160
      • Tekton Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia, LLC
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital / Tower Health
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Biocentric Health Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, LLC
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Signature Gyn Services
    • Houston, Texas, United States, 77024
      • UT Health Women's Research Center at Memorial City
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc
    • Houston, Texas, United States, 77084
      • Biopharma Informatic Research Center
    • Plano, Texas, United States, 75024
      • ClinRx Research LLC
    • San Antonio, Texas, United States, 78258
      • DCT - Stone Oak, LLC dba Discovery Clinical Trials
  • Utah
    • Riverton, Utah, United States, 84065
      • Granger Medical Clinic
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants experiencing bothersome VMS with a confirmed diagnosis of VMS by an HCP and newly prescribed non-hormonal therapy (non-HT).

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neurokinin 3 Receptor (NK3-R) Antagonist; Participants prescribed NK3-R Antagonist for the treatment of VMS.	Drug: Fezolinetant; Oral; Other Names: ESN364; VEOZAH
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI); Participants prescribed SSRI/SNRI for the treatment of VMS.	Drug: Paroxetine; Oral; Drug: Citalopram; Oral; Drug: Escitalopram; Oral; Drug: Desvenlafaxine; Oral; Drug: Venlafaxine; Oral; Drug: Any other SSRI/SNRI not already specified; Oral
Other; Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.	Drug: Gabapentin; Oral; Drug: Clonidine; Oral; Drug: Pregabalin; Oral; Drug: Oxybutynin; Oral; Drug: Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	Baseline to weeks 4, 8, 12, 24 and 52
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.	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.	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.	Up to 52 weeks
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.	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	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.	Baseline to weeks 4, 8 and 12

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.
• Investigators: Study Director: Central Contact, Astellas Pharma Global Development, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): September 6, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: vasomotor symptoms; menopause; fezolinetant; night sweats; non-hormonal treatment
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hot Flashes; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lipids; Azoles; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Imidazoles; Amines; Piperidines; Amino Acids; Phenols; Benzene Derivatives; Nitriles; Alcohols; Phenethylamines; Ethylamines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Propylamines; Cyclohexanecarboxylic Acids; Cyclohexanols; Hexanols; Fatty Alcohols; Imidazolines; Benzofurans; Gabapentin; Pregabalin; Desvenlafaxine Succinate; Venlafaxine Hydrochloride; Escitalopram; Clonidine; Citalopram; Paroxetine; fezolinetant; oxybutynin
• Other Study ID Numbers: 2693-MA-3457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No