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New hope for menopause: Non-Hormonal drugs ease hot flashes in Real-World study

NCT ID NCT06049797

Symptom relief Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed nearly 1,000 menopausal women who were starting a non-hormonal treatment for bothersome hot flashes and night sweats. Researchers tracked how much their symptoms improved after 12 weeks, along with changes in sleep, work productivity, and overall well-being. The goal was to see how these treatments work in everyday life, not just in a lab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

999 people

The number who actually took part.

Started

Nov 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

40 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hot Flashes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hot flashes

Contacts and locations

Locations

  • Accel Research Sites

    DeLand, Florida, 32720, United States

  • Accel Research Sites-Cahaba Medical Care-OBGYN

    Birmingham, Alabama, 35218, United States

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30342, United States

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35205, United States

  • Alpha Clinical Research Georgia

    Dunwoody, Georgia, 30350, United States

  • Altus Research

    Lake Worth, Florida, 33461, United States

  • Bayview Research Group, LLC

    Valley Village, California, 91607, United States

  • Biocentric Health Research

    West Columbia, South Carolina, 29169, United States

  • Biopharma Informatic Research Center

    Houston, Texas, 77084, United States

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109, United States

  • Chattanooga Medical Research, Llc

    Chattanooga, Tennessee, 37404, United States

  • Chicago Clinical Research Institute Inc.

    Chicago, Illinois, 60607, United States

  • ClinRx Research LLC

    Plano, Texas, 75024, United States

  • Clinical Research Of Philadelphia, Llc

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Complete Health Research

    Ormond Beach, Florida, 32174, United States

  • Comprehensive Clinical Trials, Llc

    West Palm Beach, Florida, 33409, United States

  • DCT - Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas, 78258, United States

  • Dr. Jarrett's Wellness Center

    Miami, Florida, 33186, United States

  • Dream Team Clinical Research

    Pomona, California, 91767, United States

  • Eastern Carolina Women's Center

    New Bern, North Carolina, 28562, United States

  • Granger Medical Clinic

    Riverton, Utah, 84065, United States

  • HWC Women's Research Center

    Englewood, Ohio, 45322, United States

  • Investigators Research Group, Llc

    Brownsburg, Indiana, 46112, United States

  • Millennium Clinical Trials LLC

    Simi Valley, California, 93065, United States

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808, United States

  • Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC)

    Lake City, Florida, 32055, United States

  • Nextlevel Research Center

    Doral, Florida, 33172, United States

  • Pioneer Research Solutions, Inc

    Houston, Texas, 77099, United States

  • Praetorian Pharmaceutical Research

    Marrero, Louisiana, 70072, United States

  • Precision Trials AZ, LLC

    Phoenix, Arizona, 85032, United States

  • Premier Gynecology & Wellness

    Charlotte, North Carolina, 28207, United States

  • Reading Hospital / Tower Health

    West Reading, Pennsylvania, 19611, United States

  • Rosemark Women Care Specialists

    Idaho Falls, Idaho, 83404, United States

  • Saginaw Valley Medical Research Group, LLC

    Saginaw, Michigan, 48604, United States

  • Seattle Clinical Research Center

    Seattle, Washington, 98104, United States

  • Signature Gyn Services

    Fort Worth, Texas, 76104, United States

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001, United States

  • Suncoast Research Associates, LLC

    Miami, Florida, 33173, United States

  • TMC Life Research, Inc

    Houston, Texas, 77054, United States

  • Tekton Research

    Moore, Oklahoma, 73160, United States

  • Tidewater Physicians for Women

    Norfolk, Virginia, 23502, United States

  • Torrance Clinical Research Institute,Inc

    Lomita, California, 90717, United States

  • UT Health Women's Research Center at Memorial City

    Houston, Texas, 77024, United States

  • Unified Women's Clinical Research

    Winston-Salem, North Carolina, 27103, United States

  • University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221, United States

  • Wake Research - Medical Center for Clinical Research WR-MCCR, LLC

    San Diego, California, 92120, United States

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