Trial Outcomes & Findings for MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women (NCT NCT03291067)

Last Updated: 2025-12-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

375 participants

Primary outcome timeframe

Baseline, Weeks 4 and 12

Results posted on

2025-12-30

Participant Flow

One subject with dual status of the run-in-failure and randomized in error in MT-8554 5 mg group was excluded from the Randomized Population.

Participant milestones

Participant milestones
Measure	MT-8554 1mg MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg MT-8554 10mg QD, oral, 12 weeks	Placebo Placebo QD, oral, 12 weeks
Overall Study STARTED	94	92	94	94
Overall Study Treated	95	90	93	90
Overall Study COMPLETED	84	78	61	77
Overall Study NOT COMPLETED	10	14	33	17

Reasons for withdrawal

Reasons for withdrawal
Measure	MT-8554 1mg MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg MT-8554 10mg QD, oral, 12 weeks	Placebo Placebo QD, oral, 12 weeks
Overall Study Adverse Event	0	2	17	3
Overall Study Lost to Follow-up	2	1	0	1
Overall Study Physician Decision	0	0	1	0
Overall Study Protocol Violation	5	3	4	2
Overall Study Withdrawal by Subject	3	4	7	5
Overall Study Other	0	4	4	6

Baseline Characteristics

MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=90 Participants Placebo QD, oral, 12 weeks	Total n=368 Participants Total of all reporting groups	MT-8554 1mg n=95 Participants MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg n=90 Participants MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg n=93 Participants MT-8554 10mg QD, oral, 12 weeks
Age, Continuous	55.7 years STANDARD_DEVIATION 6.25 • n=164 Participants	55.2 years STANDARD_DEVIATION 6.43 • n=671 Participants	54.5 years STANDARD_DEVIATION 6.27 • n=174 Participants	54.6 years STANDARD_DEVIATION 6.62 • n=166 Participants	56.0 years STANDARD_DEVIATION 6.55 • n=167 Participants
Sex: Female, Male Female	90 Participants n=164 Participants	368 Participants n=671 Participants	95 Participants n=174 Participants	90 Participants n=166 Participants	93 Participants n=167 Participants
Sex: Female, Male Male	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=164 Participants	1 Participants n=671 Participants	0 Participants n=174 Participants	1 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Asian	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Black or African American	28 Participants n=164 Participants	92 Participants n=671 Participants	20 Participants n=174 Participants	25 Participants n=166 Participants	19 Participants n=167 Participants
Race (NIH/OMB) White	62 Participants n=164 Participants	274 Participants n=671 Participants	74 Participants n=174 Participants	64 Participants n=166 Participants	74 Participants n=167 Participants
Race (NIH/OMB) More than one race	0 Participants n=164 Participants	0 Participants n=671 Participants	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=164 Participants	1 Participants n=671 Participants	1 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment

Outcome measures

Outcome measures
Measure	MT-8554 1mg n=93 Participants MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg n=90 Participants MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg n=89 Participants MT-8554 10mg QD, oral, 12 weeks	Placebo n=91 Participants Placebo QD, oral, 12 weeks
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 Week 12	-2.91 VMS per day Standard Error 0.690	-3.11 VMS per day Standard Error 0.780	-3.38 VMS per day Standard Error 0.821	-2.78 VMS per day Standard Error 0.779
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 Week 4	-1.92 VMS per day Standard Error 0.609	-2.75 VMS per day Standard Error 0.705	-2.75 VMS per day Standard Error 0.734	-1.39 VMS per day Standard Error 0.705

PRIMARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment

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.

Outcome measures

Outcome measures
Measure	MT-8554 1mg n=93 Participants MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg n=90 Participants MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg n=89 Participants MT-8554 10mg QD, oral, 12 weeks	Placebo n=91 Participants Placebo QD, oral, 12 weeks
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12 Week 4	-0.302 VMS severity score per day Standard Error 0.0609	-0.407 VMS severity score per day Standard Error 0.0714	-0.305 VMS severity score per day Standard Error 0.0740	-0.316 VMS severity score per day Standard Error 0.0712
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12 Week 12	-0.374 VMS severity score per day Standard Error 0.0725	-0.481 VMS severity score per day Standard Error 0.0822	-0.433 VMS severity score per day Standard Error 0.0864	-0.388 VMS severity score per day Standard Error 0.0819

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment. The subjects without VMS frequency data at Week 4 were excluded from the analysis at Week 4. The subjects without VMS frequency data at Week 12 were excluded from the analysis at Week 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.

Outcome measures

Outcome measures
Measure	MT-8554 1mg n=93 Participants MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg n=90 Participants MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg n=89 Participants MT-8554 10mg QD, oral, 12 weeks	Placebo n=91 Participants Placebo QD, oral, 12 weeks
Percentage of Responders at Weeks 4 and 12 Week 4	31.8 percentage of subjects	52.4 percentage of subjects	36.1 percentage of subjects	36.0 percentage of subjects
Percentage of Responders at Weeks 4 and 12 Week 12	44.4 percentage of subjects	60.5 percentage of subjects	54.1 percentage of subjects	54.1 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment

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.

Outcome measures

Outcome measures
Measure	MT-8554 1mg n=93 Participants MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg n=90 Participants MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg n=89 Participants MT-8554 10mg QD, oral, 12 weeks	Placebo n=91 Participants Placebo QD, oral, 12 weeks
Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12 Week 4	-1.8 units on a scale Standard Error 0.49	-3.1 units on a scale Standard Error 0.51	-3.6 units on a scale Standard Error 0.55	-1.8 units on a scale Standard Error 0.50
Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12 Week 12	-3.2 units on a scale Standard Error 0.53	-2.7 units on a scale Standard Error 0.55	-2.4 units on a scale Standard Error 0.54	-3.0 units on a scale Standard Error 0.55

Adverse Events

MT-8554 1mg

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

MT-8554 5mg

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

MT-8554 10mg

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MT-8554 1mg n=95 participants at risk MT-8554 1mg QD, oral, 12 weeks	MT-8554 5mg n=90 participants at risk MT-8554 5mg QD, oral, 12 weeks	MT-8554 10mg n=93 participants at risk MT-8554 10mg QD, oral, 12 weeks	Placebo n=90 participants at risk Placebo QD, oral, 12 weeks
Nervous system disorders Transient ischaemic attack	0.00% 0/95 • Week 12 One subject was randomized to placebo group; but the subject got one week of MT-8554 1 mg treatment so that the subject was counted as MT-8554 1 mg group in the Safety Population. Total of 6 subjects (3 on placebo, 2 on MT-8554 5 mg and 1 on MT-8554 10 mg) did not take any study medication so that these subjects were excluded from the Safety Population.	1.1% 1/90 • Week 12 One subject was randomized to placebo group; but the subject got one week of MT-8554 1 mg treatment so that the subject was counted as MT-8554 1 mg group in the Safety Population. Total of 6 subjects (3 on placebo, 2 on MT-8554 5 mg and 1 on MT-8554 10 mg) did not take any study medication so that these subjects were excluded from the Safety Population.	0.00% 0/93 • Week 12 One subject was randomized to placebo group; but the subject got one week of MT-8554 1 mg treatment so that the subject was counted as MT-8554 1 mg group in the Safety Population. Total of 6 subjects (3 on placebo, 2 on MT-8554 5 mg and 1 on MT-8554 10 mg) did not take any study medication so that these subjects were excluded from the Safety Population.	0.00% 0/90 • Week 12 One subject was randomized to placebo group; but the subject got one week of MT-8554 1 mg treatment so that the subject was counted as MT-8554 1 mg group in the Safety Population. Total of 6 subjects (3 on placebo, 2 on MT-8554 5 mg and 1 on MT-8554 10 mg) did not take any study medication so that these subjects were excluded from the Safety Population.

Other adverse events

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma America, Inc.

Phone: Please e-mail

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER