Vasomotor Symptoms (VMS)Phase 2NCT03541200

Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

A Phase 2 study testing MT-8554 in people with Vasomotor Symptoms (VMS), run by Tanabe Pharma America, Inc. at 53 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01 Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Vasomotor Symptoms (VMS)
What is being tested?: MT-8554
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: 53 sitesUnited States
Study dates: 18 Apr 2018to 15 Nov 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent to participate in this study.
Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

Who cannot join

Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)

Trial locations and contacts

53 sites in 1 country.

City, postcode or hospital

53 sites in 1 country

United States53 sites

Research Site
Baltimore, Maryland, 21208
Research Site
Birmingham, Alabama, 35209
Research Site
Bristol, Tennessee, 37620
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Clearwater, Florida, 33759
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Cleveland, Ohio, 44101
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Columbus, Ohio, 43213
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Columbus, Ohio, 43231
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Crystal River, Florida, 34429
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Denver, Colorado, 80209
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Dothan, Alabama, 36303
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Draper, Utah, 84020
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Englewood, Ohio, 45322
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Fort Myers, Florida, 33900
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Fort Worth, Texas, 76104
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Hialeah, Florida, 33012
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Hialeah, Florida, 33016
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Hutchinson, Kansas, 67501
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Idaho Falls, Idaho, 83404
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32256
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Jupiter, Florida, 33458
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Kalamazoo, Michigan, 49009
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Kansas City, Missouri, 64114
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Las Vegas, Nevada, 89128
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Lawrenceville, New Jersey, 08648
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Marrero, Louisiana, 70072
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Memphis, Tennessee, 38119
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Metairie, Louisiana, 70001
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Miami, Florida, 33176
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Miami, Florida, 33185
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Missoula, Montana, 59801
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Morehead City, North Carolina, 28557
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New London, Connecticut, 33176
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Norfolk, Virginia, 23502
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Norwalk, California, 90650
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Orlando, Florida, 32801
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 19114
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Phoenix, Arizona, 85032
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Ponte Vedra, Florida, 32081
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Port Saint Lucie, Florida, 34952
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Sacramento, California, 94203
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Saginaw, Michigan, 48504
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Salt Lake City, Utah, 84107
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San Diego, California, 92111
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Sandy Springs, Georgia, 30328
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Sarasota, Florida, 34231
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Schertz, Texas, 78154
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Seattle, Washington, 98101
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Wellington, Florida, 33414
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West Palm Beach, Florida, 33409
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Wichita, Kansas, 67226
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Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: An Open-label, Long Term Extension Study of MT-8554 in Postmenopausal Women Experiencing Moderate to Severe Vasomotor Symptoms Who Completed Study MT-8554-A01

An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01

Conditions: Vasomotor Symptoms (VMS)
Being tested: MT-8554

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-8554Drug
MT-8554 Oral

Study groups in NCT03541200
Study group	Role	What they receive
Open Label	Experimental	MT-8554 Receives: Drug: MT-8554

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Adverse Events
Measured: 52 Weeks
Percentage of Subjects With Serious Adverse Events
Measured: 52 Weeks
Percentage of Subjects With Clinical Laboratory Tests Abnormalities
Hematology, biochemistry, coagulation and urinalysis
Measured: 52 Weeks
Change in Blood Pressure
Systolic and diastolic blood pressure
Measured: Baseline and 52 Weeks
Change in Heart Rate
Measured: Baseline and 52 Weeks
Change in ECG Parameters
PR, QRS, QT and QTc
Measured: Baseline and 52 Weeks
Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
Measured: Baseline and 52 Weeks
Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
Measured: 52 Weeks

Secondary outcomes (2)

Change in Average Daily Frequency of Moderate to Severe VMS
Subjects were asked to record frequency and severity of VMS in an electronic diary. Severity levels are defined as follows.
Mild : Sensation of heat without sweating
Moderate : Sensation of heat with sweating, able to continue activity
Severe : Sensation of heat with sweating, causing cessation of activity
Measured: Baseline and 52 Weeks
Change in Average Daily Severity Score of Mild to Severe VMS
Baseline VMS severity score : (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse)
VMS severity score for a specific week during the open label treatment period :(1xFmi+2xFmo+3xFse)/(Fmi+Fmo+Fse)
Fmi, Fmo, and Fse are the daily frequencies of mild, moderate, and severe VMS respectively.
The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity).
Measured: Baseline and 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201815 Nov 2019

First posted30 May 2018
Study start18 Apr 2018
Primary completion15 Nov 2019
Study completion15 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vasomotor Symptoms (VMS)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03541200
Sponsor's protocol ID: MT-8554-A02
Status last verified: Jan 2026
First submitted: 29 Mar 2018
Last updated: 23 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Menopause, Vasomotor Symptoms (VMS)
RecruitingPhase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Vasomotor Symptoms
Not yet recruitingObservational study
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
Vasomotor Symptoms (VMS) Associated With Menopause
Not yet recruiting
ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
Women in the Menopausal Period
Recruiting
Impact of Lean Pork on Endothelial Function in Perimenopause
Cardiovascular Outcome, Overweight and Obese Women

All Vasomotor Symptoms (VMS) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Long Term Extension Study of MT-8554 in Postmenopausal Women Experiencing Moderate to Severe Vasomotor Symptoms Who Completed Study MT-8554-A01
ClinicalTrials.gov ID: NCT03541200
Acronym / sponsor ID: MT-8554-A02
Conditions: Vasomotor Symptoms (VMS)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: 18 Apr 2018 (actual)
Primary completion: 15 Nov 2019 (actual)
Study completion: 15 Nov 2019 (actual)
First posted: 30 May 2018 (actual)
Results: Posted 3 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open Label	Experimental	Drug: MT-8554MT-8554

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Signed informed consent to participate in this study.
Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

Key exclusion criteria (1 listed)

Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MT-8554MT-8554 Oral	Drug	Open Label

Primary outcome

Percentage of Subjects With Adverse Events
Time frame: 52 Weeks
Percentage of Subjects With Serious Adverse Events
Time frame: 52 Weeks
Percentage of Subjects With Clinical Laboratory Tests Abnormalities
Time frame: 52 Weeks
Hematology, biochemistry, coagulation and urinalysis
Change in Blood Pressure
Time frame: Baseline and 52 Weeks
Systolic and diastolic blood pressure
Change in Heart Rate
Time frame: Baseline and 52 Weeks
Change in ECG Parameters
Time frame: Baseline and 52 Weeks
PR, QRS, QT and QTc
Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
Time frame: Baseline and 52 Weeks
Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
Time frame: 52 Weeks

2 secondary outcomes

Change in Average Daily Frequency of Moderate to Severe VMS
Time frame: Baseline and 52 Weeks
Change in Average Daily Severity Score of Mild to Severe VMS
Time frame: Baseline and 52 Weeks

Results and safety

Results posted to the registry on 3 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MT-8554	190	77

Primary outcome: Percentage of Subjects With Adverse Events

Time frame: 52 Weeks. Number. Unit: percentage of subjects

Measure	MT-8554 n = 187
Value	56.7

Population analysed: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.

Primary outcome: Percentage of Subjects With Serious Adverse Events

Time frame: 52 Weeks. Number. Unit: percentage of subjects

Measure	MT-8554 n = 187
Value	3.2

Population analysed: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.

Primary outcome: Percentage of Subjects With Clinical Laboratory Tests Abnormalities

Time frame: 52 Weeks. Number. Unit: percentage of subjects

Measure	MT-8554 n = 187
Value	15.5

Population analysed: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population.

Primary outcome: Change in Blood Pressure

Time frame: Baseline and 52 Weeks. Mean (Standard Deviation). Unit: mmHg

Measure	MT-8554 n = 187
Systolic Blood Pressure	1.3 (11.36)
Diastolic Blood Pressure	-0.4 (7.65)

Population analysed: 3 subjects did not take any study medication so these subjects were excluded from the Safety Population. The number of subjects with SBP and DBP results at Week 52 are mentioned in each row "number of participants analyzed".

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MT-8554	6 of 187 (3.2%)	91 of 187 (48.7%)	1 of 187

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vasomotor Symptoms (VMS)

Not yet recruiting
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Menopause, Vasomotor Symptoms (VMS)
RecruitingPhase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Vasomotor Symptoms
Not yet recruitingObservational study
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
Vasomotor Symptoms (VMS) Associated With Menopause
Not yet recruiting
ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
Women in the Menopausal Period
Recruiting
Impact of Lean Pork on Endothelial Function in Perimenopause
Cardiovascular Outcome, Overweight and Obese Women

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Head of Medical Science study director

Tanabe Pharma America, Inc.

53 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MT-8554 in people with Vasomotor Symptoms (VMS), run by Tanabe Pharma America, Inc. at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Adverse Events (time frame: 52 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.