MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
NCT03291067 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 375
Last updated 2026-01-23
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.
Conditions
- Menopause Hot Flashes
Interventions
- DRUG
-
MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks
- DRUG
-
MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks
- DRUG
-
MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks
- DRUG
-
Placebo QD, oral, 12 weeks
Sponsors & Collaborators
-
Tanabe Pharma America, Inc.
lead INDUSTRY
Principal Investigators
-
Head of Medical Science · Tanabe Pharma America, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-09
- Primary Completion
- 2018-10-19
- Completion
- 2018-11-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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