MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

What this trial studies

The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

Conditions in scope

• Menopause Hot Flashes

Interventions

• MT-8554 1mg (Drug) — MT-8554 1mg QD, oral, 12 weeks
• MT-8554 5mg (Drug) — MT-8554 5mg QD, oral, 12 weeks
• MT-8554 10mg (Drug) — MT-8554 10mg QD, oral, 12 weeks
• Placebo (Drug) — Placebo QD, oral, 12 weeks

Who can join

Women only · Ages 18 Years and up

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
• 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 significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 63 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2017-10-09
• Primary completion: 2018-10-19
• Last update posted: 2026-01-23
• First posted: 2017-09-25

Sponsor & contact

Lead sponsor: Tanabe Pharma America, Inc. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 (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 (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…

Related ClearedRx care

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