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A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Sponsor: Astellas Pharma Global Development, Inc.
Summary
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined.
Official title: A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
Key Details
Gender
FEMALE
Age Range
40 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
999
Start Date
2023-11-15
Completion Date
2026-05-31
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Fezolinetant
Oral
Paroxetine
Oral
Citalopram
Oral
Escitalopram
Oral
Desvenlafaxine
Oral
Venlafaxine
Oral
Gabapentin
Oral
Clonidine
Oral
Pregabalin
Oral
Oxybutynin
Oral
Any other SSRI/SNRI not already specified
Oral
Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above
Oral
Locations (48)
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Accel Research Sites-Cahaba Medical Care-OBGYN
Birmingham, Alabama, United States
Precision Trials AZ, LLC
Phoenix, Arizona, United States
Torrance Clinical Research Institute,Inc
Lomita, California, United States
Dream Team Clinical Research
Pomona, California, United States
Wake Research - Medical Center for Clinical Research WR-MCCR, LLC
San Diego, California, United States
Millennium Clinical Trials LLC
Simi Valley, California, United States
Bayview Research Group, LLC
Valley Village, California, United States
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
Aurora, Colorado, United States
Accel Research Sites
DeLand, Florida, United States
Nextlevel Research Center
Doral, Florida, United States
Multi-Specialty Research Associates, Inc. (WR-MSRA, LLC)
Lake City, Florida, United States
Altus Research
Lake Worth, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Dr. Jarrett's Wellness Center
Miami, Florida, United States
Complete Health Research
Ormond Beach, Florida, United States
Comprehensive Clinical Trials, Llc
West Palm Beach, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Alpha Clinical Research Georgia
Dunwoody, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, United States
Investigators Research Group, Llc
Brownsburg, Indiana, United States
Praetorian Pharmaceutical Research
Marrero, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Premier Gynecology & Wellness
Charlotte, North Carolina, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
HWC Women's Research Center
Englewood, Ohio, United States
Tekton Research
Moore, Oklahoma, United States
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, United States
Reading Hospital / Tower Health
West Reading, Pennsylvania, United States
Biocentric Health Research
West Columbia, South Carolina, United States
Chattanooga Medical Research, Llc
Chattanooga, Tennessee, United States
Signature Gyn Services
Fort Worth, Texas, United States
UT Health Women's Research Center at Memorial City
Houston, Texas, United States
TMC Life Research, Inc
Houston, Texas, United States
Biopharma Informatic Research Center
Houston, Texas, United States
Pioneer Research Solutions, Inc
Houston, Texas, United States
ClinRx Research LLC
Plano, Texas, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Granger Medical Clinic
Riverton, Utah, United States
Tidewater Physicians for Women
Norfolk, Virginia, United States
Seattle Clinical Research Center
Seattle, Washington, United States