MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

Completed · Phase 2 · Has a placebo group

Conditions studied: Menopause Hot Flashes

In brief

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

Key facts

Study ID: NCT03291067
Run by: Tanabe Pharma America, Inc.
People needed: 375
Starts: 2017-10-09
Expected to finish: 2018-11-09
Last updated by the study team: 2026-01-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — New London, Connecticut, United States
Research Site — New London, Connecticut, United States
Research Site — Aventura, Florida, United States
Research Site — Clearwater, Florida, United States
Research Site — Crystal River, Florida, United States
Research Site — Fort Myers, Florida, United States
Research Site — Hialeah, Florida, United States
Research Site — Hialeah, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Jupiter, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Ponte Vedra, Florida, United States
Research Site — Port Saint Lucie, Florida, United States
Research Site — Sarasota, Florida, United States
Research Site — Sarasota, Florida, United States
Research Site — Wellington, Florida, United States
Research Site — West Palm Beach, Florida, United States
Research Site — Sandy Springs, Georgia, United States
Research Site — Idaho Falls, Idaho, United States
Research Site — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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