CompletedPhase 2

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

United States190 participantsStarted 2018-04-18

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Subjects With Adverse Events

Timeframe: 52 Weeks

Percentage of Subjects With Serious Adverse Events

Timeframe: 52 Weeks

Percentage of Subjects With Clinical Laboratory Tests Abnormalities

Timeframe: 52 Weeks

Change in Blood Pressure

Timeframe: Baseline and 52 Weeks

Change in Heart Rate

Timeframe: Baseline and 52 Weeks

Change in ECG Parameters

Timeframe: Baseline and 52 Weeks

Change in Endometrial Thickness as Measured by Transvaginal Ultrasound

Timeframe: Baseline and 52 Weeks

Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy

Trial details

NCT IDNCT03541200

SponsorTanabe Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-15

Results submitted2022-06-26

View on ClinicalTrials.gov More Vasomotor Symptoms (VMS) trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Subjects With Adverse Events

Timeframe: 52 Weeks

Percentage of Subjects With Serious Adverse Events

Timeframe: 52 Weeks

Percentage of Subjects With Clinical Laboratory Tests Abnormalities

Timeframe: 52 Weeks

Change in Blood Pressure

Timeframe: Baseline and 52 Weeks

Change in Heart Rate

Timeframe: Baseline and 52 Weeks

Change in ECG Parameters

Timeframe: Baseline and 52 Weeks

Change in Endometrial Thickness as Measured by Transvaginal Ultrasound

Timeframe: Baseline and 52 Weeks

Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy