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MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT03291067
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Drug: MT-8554 Low dose Drug: MT-8554 Medium dose Drug: MT-8554 High dose Drug: Placebo Phase 2

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 sweating, able to continue activity
  • Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arms and Interventions
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Arm Intervention/treatment
Experimental: MT-8554 Low dose Drug: MT-8554 Low dose
MT-8554 Low dose QD, oral, 12 weeks
Experimental: MT-8554 Medium dose Drug: MT-8554 Medium dose
MT-8554 Medium dose QD, oral, 12 weeks
Experimental: MT-8554 High dose Drug: MT-8554 High dose
MT-8554 High dose QD, oral, 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo QD, oral, 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the average daily frequency of moderate to severe VMS at Weeks 4 Week 12 [ Time Frame: Week 4 and Week 12 ]
  2. Change from baseline in the average daily severity score of mild to severe VMS at Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ]

Secondary Outcome Measures :
  1. Proportion of responders at Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291067


  Show 63 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT03291067     History of Changes
Other Study ID Numbers: MT-8554-A01
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms