Menopause Hot Flashes Clinical Trial
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
| Verified date | May 2023 |
| Source | Mitsubishi Tanabe Pharma America Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
| Status | Completed |
| Enrollment | 375 |
| Est. completion date | November 9, 2018 |
| Est. primary completion date | October 19, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Ankeny | Iowa |
| United States | Research Site | Aventura | Florida |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Bristol | Tennessee |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Covington | Washington |
| United States | Research Site | Crystal River | Florida |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Dothan | Alabama |
| United States | Research Site | Draper | Utah |
| United States | Research Site | Englewood | Ohio |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Idaho Falls | Idaho |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jupiter | Florida |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lawrenceville | New Jersey |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Missoula | Montana |
| United States | Research Site | Morehead City | North Carolina |
| United States | Research Site | New London | Connecticut |
| United States | Research Site | New London | Connecticut |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Norwalk | California |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Ponte Vedra | Florida |
| United States | Research Site | Port Saint Lucie | Florida |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Diego | California |
| United States | Research Site | Sandy Springs | Georgia |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Schertz | Texas |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Wellington | Florida |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Mitsubishi Tanabe Pharma America Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at 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. | Baseline, Weeks 4 and 12 | |
| Primary | Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at 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. | Baseline, Weeks 4 and 12 | |
| Secondary | Percentage of Responders at Weeks 4 and 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. | Week 4 and Week 12 | |
| Secondary | Change From Baseline in the Insomnia Severity Index at Week 4 and Week 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. | Baseline, Weeks 4 and 12 |