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MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291067
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : January 4, 2022
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

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 1mg Drug: MT-8554 5mg Drug: MT-8554 10mg 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 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
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : November 9, 2018

Arm Intervention/treatment
Experimental: MT-8554 1mg Drug: MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks

Experimental: MT-8554 5mg Drug: MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks

Experimental: MT-8554 10mg Drug: MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo QD, oral, 12 weeks




Primary Outcome Measures :
  1. Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.

  2. Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.


Secondary Outcome Measures :
  1. Percentage of Responders at Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ]
    Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.

  2. Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12 [ Time Frame: Baseline, Weeks 4 and 12 ]
    The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia.



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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

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


Locations
Show Show 63 study locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
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Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
  Study Documents (Full-Text)

Documents provided by Mitsubishi Tanabe Pharma Development America, Inc.:
Study Protocol  [PDF] March 22, 2018
Statistical Analysis Plan  [PDF] November 1, 2018

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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT03291067    
Other Study ID Numbers: MT-8554-A01
First Posted: September 25, 2017    Key Record Dates
Results First Posted: January 4, 2022
Last Update Posted: January 4, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hot Flashes