Menopause Hot FlashesPhase 2NCT03291067
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
A Phase 2 study testing MT-8554 1mg, MT-8554 5mg and MT-8554 10mg in people with Menopause Hot Flashes, run by Tanabe Pharma America, Inc. at 63 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menopause Hot Flashes
- What is being tested?
- MT-8554 1mg, MT-8554 5mg and MT-8554 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 63 sitesUnited States
- Study dates
- 9 Oct 2017to 9 Nov 2018
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Research Site
Ankeny, Iowa, 50023
Research Site
Aventura, Florida, 33180
Research Site
Baltimore, Maryland, 21208
Research Site
Birmingham, Alabama, 35209
Research Site
Bristol, Tennessee, 37620
Research Site
Clearwater, Florida, 33759
Research Site
Cleveland, Ohio, 44122
Research Site
Columbus, Ohio, 43213
Research Site
Columbus, Ohio, 43231
Research Site
Covington, Washington, 98042
Research Site
Crystal River, Florida, 34429
Research Site
Denver, Colorado, 80209
Research Site
Dothan, Alabama, 36303
Research Site
Draper, Utah, 84020
Research Site
Englewood, Ohio, 45322
Research Site
Fort Myers, Florida, 33912
Research Site
Fort Worth, Texas, 76104
Research Site
Hialeah, Florida, 33012
Research Site
Hialeah, Florida, 33016
Research Site
Idaho Falls, Idaho, 83404
Research Site
Jackson, Tennessee, 38305
Research Site
Jacksonville, Florida, 32216
Research Site
Jacksonville, Florida, 32256
Research Site
Jupiter, Florida, 33458
Research Site
Kalamazoo, Michigan, 49009
Research Site
Kansas City, Missouri, 64114
Research Site
Knoxville, Tennessee, 37920
Research Site
Las Vegas, Nevada, 89113
Research Site
Las Vegas, Nevada, 89128
Research Site
Lawrenceville, New Jersey, 08648
Research Site
Marrero, Louisiana, 70072
Research Site
Memphis, Tennessee, 38119
Research Site
Metairie, Louisiana, 70001
Research Site
Miami, Florida, 33176
Research Site
Miami, Florida, 33185
Research Site
Miami, Florida, 33186
Research Site
Missoula, Montana, 59808
Research Site
Morehead City, North Carolina, 28557
Research Site
New London, Connecticut, 06320
Research Site
New London, Connecticut, 33176
Research Site
Norfolk, Virginia, 23502
Research Site
Norwalk, California, 90650
Research Site
Ogden, Utah, 84403
Research Site
Orlando, Florida, 32801
Research Site
Orlando, Florida, 32806
Research Site
Philadelphia, Pennsylvania, 19114
Research Site
Phoenix, Arizona, 85032
Research Site
Ponte Vedra, Florida, 32081
Research Site
Port Saint Lucie, Florida, 34952
Research Site
Sacramento, California, 95821
Research Site
Saginaw, Michigan, 48504
Research Site
Saginaw, Michigan, 48604
Research Site
Salt Lake City, Utah, 84107
Research Site
San Diego, California, 92111
Research Site
Sandy Springs, Georgia, 30328
Research Site
Sarasota, Florida, 34231
Research Site
Sarasota, Florida, 34239
Research Site
Schertz, Texas, 78154
Research Site
Seattle, Washington, 98105
Research Site
Wellington, Florida, 33414
Research Site
West Palm Beach, Florida, 33409
Research Site
Wichita, Kansas, 67226
Research Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
Read the detailed description
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:
- Moderate: sensation of heat with sweating, able to continue activity
- Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.
- Conditions
- Menopause Hot Flashes
- Being tested
- MT-8554 1mg, MT-8554 5mg, MT-8554 10mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-8554 1mgDrug
MT-8554 1mg QD, oral, 12 weeks
MT-8554 5mgDrug
MT-8554 5mg QD, oral, 12 weeks
MT-8554 10mgDrug
MT-8554 10mg QD, oral, 12 weeks
PlaceboDrug
Placebo QD, oral, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| MT-8554 1mg | Experimental | Not described Receives: Drug: MT-8554 1mg |
| MT-8554 5mg | Experimental | Not described Receives: Drug: MT-8554 5mg |
| MT-8554 10mg | Experimental | Not described Receives: Drug: MT-8554 10mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12
The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Measured: Baseline, Weeks 4 and 12
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12
The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Measured: Baseline, Weeks 4 and 12
Secondary outcomes (2)
Percentage of Responders at Weeks 4 and 12
Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.
Measured: Week 4 and Week 12
Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12
The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia.
Measured: Baseline, Weeks 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start9 Oct 2017
- Primary completion19 Oct 2018
- Study completion9 Nov 2018
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 Menopause Hot FlashesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Medical Science, Study director, Tanabe Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291067
- Sponsor's protocol ID
- MT-8554-A01
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2017
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
- A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03291067
- Acronym / sponsor ID
- MT-8554-A01
- Conditions
- Menopause Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 4 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
Detailed description
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:
- Moderate: sensation of heat with sweating, able to continue activity
- Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT-8554 1mg | Experimental | Drug: MT-8554 1mg |
| MT-8554 5mg | Experimental | Drug: MT-8554 5mg |
| MT-8554 10mg | Experimental | Drug: MT-8554 10mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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-8554 1mgMT-8554 1mg QD, oral, 12 weeks | Drug | MT-8554 1mg |
| MT-8554 5mgMT-8554 5mg QD, oral, 12 weeks | Drug | MT-8554 5mg |
| MT-8554 10mgMT-8554 10mg QD, oral, 12 weeks | Drug | MT-8554 10mg |
| PlaceboPlacebo QD, oral, 12 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12
Time frame: Baseline, Weeks 4 and 12
The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12
Time frame: Baseline, Weeks 4 and 12
The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
2 secondary outcomes
Percentage of Responders at Weeks 4 and 12
Time frame: Week 4 and Week 12
Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12
Time frame: Baseline, Weeks 4 and 12
Results and safety
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 Menopause Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Not yet recruiting
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
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.
63 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 1mg, MT-8554 5mg and MT-8554 10mg in people with Menopause Hot Flashes, run by Tanabe Pharma America, Inc. at 63 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 8 inclusion and 12 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 63 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. Some participants in this study may receive a placebo. 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 4 Jan 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?
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 (time frame: Baseline, Weeks 4 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.