Status:
COMPLETED
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
Lead Sponsor:
Tanabe Pharma America, Inc.
Conditions:
Menopause Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows: * Moderate: sensation of heat with sw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2018
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT03291067
Start Date
October 9 2017
End Date
November 9 2018
Last Update
December 30 2025
Active Locations (63)
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1
Research Site
Birmingham, Alabama, United States, 35209
2
Research Site
Dothan, Alabama, United States, 36303
3
Research Site
Phoenix, Arizona, United States, 85032
4
Research Site
Norwalk, California, United States, 90650