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ACTIVE NOT RECRUITING
NCT06049797

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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

DRUG

Fezolinetant

Oral

DRUG

Paroxetine

Oral

DRUG

Citalopram

Oral

DRUG

Escitalopram

Oral

DRUG

Desvenlafaxine

Oral

DRUG

Venlafaxine

Oral

DRUG

Gabapentin

Oral

DRUG

Clonidine

Oral

DRUG

Pregabalin

Oral

DRUG

Oxybutynin

Oral

DRUG

Any other SSRI/SNRI not already specified

Oral

DRUG

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