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
1 other identifier
observational
999
1 country
48
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Typical duration for all trials
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2026
CompletedJune 5, 2026
May 1, 2026
1.8 years
September 18, 2023
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (24)
Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain
Up to week 52
Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain
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
Baseline and weeks 4, 8, 12, 24 and 52
Total score from Patient Global Impression of Severity (PGI-S) of SD
Up to week 52
Total score from Patient Global Impression of Change (PGI-C) of SD
Up to week 52
- +19 more secondary outcomes
Study Arms (3)
Neurokinin 3 Receptor (NK3-R) Antagonist
Participants prescribed NK3-R Antagonist for the treatment of VMS.
Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
Participants prescribed SSRI/SNRI for the treatment of VMS.
Other
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
Interventions
Oral
Oral
Oral
Oral
Oral
Oral
Oral
Eligibility Criteria
Participants experiencing bothersome VMS with a confirmed diagnosis of VMS by an HCP and newly prescribed non-hormonal therapy (non-HT).
You may qualify if:
- 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).
You may not qualify if:
- 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.)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35205, United States
Accel Research Sites-Cahaba Medical Care-OBGYN
Birmingham, Alabama, 35218, United States
Precision Trials AZ, LLC
Phoenix, Arizona, 85032, United States
Torrance Clinical Research Institute,Inc
Lomita, California, 90717, United States
Dream Team Clinical Research
Pomona, California, 91767, United States
Wake Research - Medical Center for Clinical Research WR-MCCR, LLC
San Diego, California, 92120, United States
Millennium Clinical Trials LLC
Simi Valley, California, 93065, United States
Bayview Research Group, LLC
Valley Village, California, 91607, United States
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Accel Research Sites
DeLand, Florida, 32720, United States
Nextlevel Research Center
Doral, Florida, 33172, United States
Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC)
Lake City, Florida, 32055, United States
Altus Research
Lake Worth, Florida, 33461, United States
Suncoast Research Associates, LLC
Miami, Florida, 33173, United States
Dr. Jarrett's Wellness Center
Miami, Florida, 33186, United States
Complete Health Research
Ormond Beach, Florida, 32174, United States
Comprehensive Clinical Trials, Llc
West Palm Beach, Florida, 33409, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30342, United States
Alpha Clinical Research Georgia
Dunwoody, Georgia, 30350, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607, United States
Investigators Research Group, Llc
Brownsburg, Indiana, 46112, United States
Praetorian Pharmaceutical Research
Marrero, Louisiana, 70072, United States
Southern Clinical Research Associates
Metairie, Louisiana, 70001, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604, United States
Montana Medical Research, Inc.
Missoula, Montana, 59808, United States
Bosque Women's Care
Albuquerque, New Mexico, 87109, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Premier Gynecology & Wellness
Charlotte, North Carolina, 28207, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
Tekton Research
Moore, Oklahoma, 73160, United States
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, 19114, United States
Reading Hospital / Tower Health
West Reading, Pennsylvania, 19611, United States
Biocentric Health Research
West Columbia, South Carolina, 29169, United States
Chattanooga Medical Research, Llc
Chattanooga, Tennessee, 37404, United States
Signature Gyn Services
Fort Worth, Texas, 76104, United States
UT Health Women's Research Center at Memorial City
Houston, Texas, 77024, United States
TMC Life Research, Inc
Houston, Texas, 77054, United States
Biopharma Informatic Research Center
Houston, Texas, 77084, United States
Pioneer Research Solutions, Inc
Houston, Texas, 77099, United States
ClinRx Research LLC
Plano, Texas, 75024, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Granger Medical Clinic
Riverton, Utah, 84065, United States
Tidewater Physicians for Women
Norfolk, Virginia, 23502, United States
Seattle Clinical Research Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 22, 2023
Study Start
November 15, 2023
Primary Completion
September 6, 2025
Study Completion
May 7, 2026
Last Updated
June 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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/.