MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
Condition: Menopause Hot Flashes
MeSH terms: Hot Flashes
Intervention: MT-8554 1mg; MT-8554 5mg; MT-8554 10mg; Placebo
Intervention description: MT-8554 1mg QD, oral, 12 weeks; MT-8554 5mg QD, oral, 12 weeks; MT-8554 10mg QD, oral, 12 weeks; Placebo QD, oral, 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 375.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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 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