MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women (NCT03291067) | Clinical Trial Compass
CompletedPhase 2
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
United States375 participantsStarted 2017-10-09
Plain-language 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.
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:
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
Exclusion Criteria:
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
* Peripheral vascular disease or disorders with associated vasculopathies
* Clinically significa…
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
1
Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12
Timeframe: Baseline, Weeks 4 and 12
2
Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12