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New pill could cool down menopause hot flashes

NCT ID NCT03291067

Symptom relief Sponsor: Tanabe Pharma America, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an experimental drug called MT-8554 to see if it could reduce the number and intensity of hot flashes in women going through menopause. About 375 women who had at least 7 moderate to severe hot flashes per day took either the drug or a placebo. The goal was to find a safe and effective way to ease this common menopause symptom.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

375 people

The number who actually took part.

Started

Oct 2017

Finished

Nov 2018

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.

Ages

18 years and older

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: Additional screening criteria check may apply for qualification: * Provide written informed consent to participate in this study * Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels \>40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy * 7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week * Have a consistent bedtime on at least 5 nights per week * Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period * VMS diary compliance \>50% * In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements Exclusion Criteria: Additional screening criteria check may apply for qualification: * History of any cancer within 5 years except for basal cell carcinoma * History of undiagnosed abnormal vaginal bleeding * History of Hepatitis B, Hepatitis C or HIV * History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance * Presence or history of severe adverse reaction or allergy to any drug * Peripheral vascular disease or disorders with associated vasculopathies * Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator * Endometrial thickness of \>=5 mm as measured by transvaginal ultrasound * Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer) * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range * Subjects of childbearing potential

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As listed by the trial registrant

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

Menopause hot flashes

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35209, United States

  • Research Site

    Dothan, Alabama, 36303, United States

  • Research Site

    Phoenix, Arizona, 85032, United States

  • Research Site

    Norwalk, California, 90650, United States

  • Research Site

    Sacramento, California, 95821, United States

  • Research Site

    San Diego, California, 92111, United States

  • Research Site

    Denver, Colorado, 80209, United States

  • Research Site

    New London, Connecticut, 06320, United States

  • Research Site

    New London, Connecticut, 33176, United States

  • Research Site

    Aventura, Florida, 33180, United States

  • Research Site

    Clearwater, Florida, 33759, United States

  • Research Site

    Crystal River, Florida, 34429, United States

  • Research Site

    Fort Myers, Florida, 33912, United States

  • Research Site

    Hialeah, Florida, 33012, United States

  • Research Site

    Hialeah, Florida, 33016, United States

  • Research Site

    Jacksonville, Florida, 32216, United States

  • Research Site

    Jacksonville, Florida, 32256, United States

  • Research Site

    Jupiter, Florida, 33458, United States

  • Research Site

    Miami, Florida, 33176, United States

  • Research Site

    Miami, Florida, 33185, United States

  • Research Site

    Miami, Florida, 33186, United States

  • Research Site

    Orlando, Florida, 32801, United States

  • Research Site

    Orlando, Florida, 32806, United States

  • Research Site

    Ponte Vedra, Florida, 32081, United States

  • Research Site

    Port Saint Lucie, Florida, 34952, United States

  • Research Site

    Sarasota, Florida, 34231, United States

  • Research Site

    Sarasota, Florida, 34239, United States

  • Research Site

    Wellington, Florida, 33414, United States

  • Research Site

    West Palm Beach, Florida, 33409, United States

  • Research Site

    Sandy Springs, Georgia, 30328, United States

  • Research Site

    Idaho Falls, Idaho, 83404, United States

  • Research Site

    Ankeny, Iowa, 50023, United States

  • Research Site

    Wichita, Kansas, 67226, United States

  • Research Site

    Marrero, Louisiana, 70072, United States

  • Research Site

    Metairie, Louisiana, 70001, United States

  • Research Site

    Baltimore, Maryland, 21208, United States

  • Research Site

    Kalamazoo, Michigan, 49009, United States

  • Research Site

    Saginaw, Michigan, 48504, United States

  • Research Site

    Saginaw, Michigan, 48604, United States

  • Research Site

    Kansas City, Missouri, 64114, United States

  • Research Site

    Missoula, Montana, 59808, United States

  • Research Site

    Las Vegas, Nevada, 89113, United States

  • Research Site

    Las Vegas, Nevada, 89128, United States

  • Research Site

    Lawrenceville, New Jersey, 08648, United States

  • Research Site

    Morehead City, North Carolina, 28557, United States

  • Research Site

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    Cleveland, Ohio, 44122, United States

  • Research Site

    Columbus, Ohio, 43213, United States

  • Research Site

    Columbus, Ohio, 43231, United States

  • Research Site

    Englewood, Ohio, 45322, United States

  • Research Site

    Philadelphia, Pennsylvania, 19114, United States

  • Research Site

    Bristol, Tennessee, 37620, United States

  • Research Site

    Jackson, Tennessee, 38305, United States

  • Research Site

    Knoxville, Tennessee, 37920, United States

  • Research Site

    Memphis, Tennessee, 38119, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    Schertz, Texas, 78154, United States

  • Research Site

    Draper, Utah, 84020, United States

  • Research Site

    Ogden, Utah, 84403, United States

  • Research Site

    Salt Lake City, Utah, 84107, United States

  • Research Site

    Norfolk, Virginia, 23502, United States

  • Research Site

    Covington, Washington, 98042, United States

  • Research Site

    Seattle, Washington, 98105, United States

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