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New drug shows promise for Long-Term hot flash relief

NCT ID NCT03541200

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at the long-term safety and effects of the drug MT-8554 in 190 postmenopausal women with moderate to severe hot flashes. All participants had completed a previous 12-week study of the same drug. Researchers monitored side effects, blood pressure, heart rate, and changes in the uterus lining. The goal was to see if MT-8554 remains safe and effective over a longer period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT-8554 (oral drug)
What this could lead to
If successful, this could provide a long-term treatment option for reducing hot flashes in postmenopausal women.
What could go wrong
This is a small, early-phase extension study with no placebo group, so results may not confirm effectiveness or safety for wider use.

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

190 people

The number who actually took part.

Started

Apr 2018

Finished

Nov 2019

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: * Signed informed consent to participate in this study. * Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12. Exclusion Criteria: * Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)

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As listed by the trial registrant

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

Vasomotor symptoms (VMS)

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, 94203, United States

  • Research Site

    San Diego, California, 92111, United States

  • Research Site

    Denver, Colorado, 80209, United States

  • Research Site

    New London, Connecticut, 33176, United States

  • Research Site

    Clearwater, Florida, 33759, United States

  • Research Site

    Crystal River, Florida, 34429, United States

  • Research Site

    Fort Myers, Florida, 33900, United States

  • Research Site

    Hialeah, Florida, 33012, United States

  • Research Site

    Hialeah, Florida, 33016, 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

    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

    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

    Hutchinson, Kansas, 67501, 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

    Kansas City, Missouri, 64114, United States

  • Research Site

    Missoula, Montana, 59801, 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, 44101, 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

    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

    Salt Lake City, Utah, 84107, United States

  • Research Site

    Norfolk, Virginia, 23502, United States

  • Research Site

    Seattle, Washington, 98101, United States

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