Clinical trial NCT03541200: Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms
Official title: An Open-label, Long Term Extension Study of MT-8554 in Postmenopausal Women Experiencing Moderate to Severe Vasomotor Symptoms Who Completed Study MT-8554-A01
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vasomotor Symptoms (VMS)
Lead sponsor: Mitsubishi Tanabe Pharma America Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01


Eligibility criteria: Inclusion Criteria:

* Signed informed consent to participate in this study.
* Subjects who complete the preceding trial (Study MT-8554-A01) through Week 12.

Exclusion Criteria:

* Subjects who meet the withdrawal criteria for the proceeding trial (Study MT-8554-A01)

Primary outcomes:
measure: Percentage of Subjects With Adverse Events
timeFrame: 52 Weeks
measure: Percentage of Subjects With Serious Adverse Events
timeFrame: 52 Weeks
measure: Percentage of Subjects With Clinical Laboratory Tests Abnormalities
timeFrame: 52 Weeks
measure: Change in Blood Pressure
timeFrame: Baseline and 52 Weeks
measure: Change in Heart Rate
timeFrame: Baseline and 52 Weeks
measure: Change in ECG Parameters
timeFrame: Baseline and 52 Weeks
measure: Change in Endometrial Thickness as Measured by Transvaginal Ultrasound
timeFrame: Baseline and 52 Weeks
measure: Percentage of Participants With Endometrial Hyperplasia as Measured by Endometrial Biopsy
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change in Average Daily Frequency of Moderate to Severe VMS
timeFrame: Baseline and 52 Weeks
measure: Change in Average Daily Severity Score of Mild to Severe VMS
timeFrame: Baseline and 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Norwalk
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: New London
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Crystal River
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jupiter
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Ponte Vedra
country: United States
facility: Research Site
state: Florida
city: Port Saint Lucie
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Wellington
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Sandy Springs
country: United States
facility: Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Research Site
state: Idaho
city: Hutchinson
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Marrero
country: United States
facility: Research Site
state: Louisiana
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Saginaw
country: United States
facility: Research Site
state: Michigan
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Missoula
country: United States
facility: Research Site
state: Montana
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Lawrenceville
country: United States
facility: Research Site
state: New Jersey
city: Morehead City
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Englewood
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Schertz
country: United States
facility: Research Site
state: Texas
city: Draper
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Mitsubishi Tanabe Pharma America Inc.
name: Head of Medical Science
role: STUDY_DIRECTOR
References: