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

NCT ID: NCT06049797

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 999 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Hot Flashes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neurokinin 3 Receptor (NK3-R) Antagonist

Participants prescribed NK3-R Antagonist for the treatment of VMS.

Fezolinetant

Intervention Type: DRUG

Oral

Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)

Participants prescribed SSRI/SNRI for the treatment of VMS.

Paroxetine

Intervention Type: DRUG

Oral

Citalopram

Intervention Type: DRUG

Oral

Escitalopram

Intervention Type: DRUG

Oral

Desvenlafaxine

Intervention Type: DRUG

Oral

Venlafaxine

Intervention Type: DRUG

Oral

Any other SSRI/SNRI not already specified

Intervention Type: DRUG

Oral

Other

Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.

Gabapentin

Intervention Type: DRUG

Oral

Clonidine

Intervention Type: DRUG

Oral

Pregabalin

Intervention Type: DRUG

Oral

Oxybutynin

Intervention Type: DRUG

Oral

Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above

Intervention Type: DRUG

Oral

Interventions

Fezolinetant

Oral

Intervention Type: DRUG

Paroxetine

Oral

Intervention Type: DRUG

Citalopram

Oral

Intervention Type: DRUG

Escitalopram

Oral

Intervention Type: DRUG

Desvenlafaxine

Oral

Intervention Type: DRUG

Venlafaxine

Oral

Intervention Type: DRUG

Gabapentin

Oral

Intervention Type: DRUG

Clonidine

Oral

Intervention Type: DRUG

Pregabalin

Oral

Intervention Type: DRUG

Oxybutynin

Oral

Intervention Type: DRUG

Any other SSRI/SNRI not already specified

Oral

Intervention Type: DRUG

Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above

Oral

Intervention Type: DRUG

Other Intervention Names

ESN364; VEOZAH

Eligibility Criteria

Inclusion Criteria

• Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
• HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
• Participant's health status is stable based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.
• If participant has been prescribed an SSRI or SNRI for the treatment of depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months prior to screening.
• Participant has a negative urine pregnancy test at screening if not post-menopausal.
• Only for participants utilizing complementary and alternative therapies, mind-body techniques, or supplements for the treatment of VMS: participant has been on such therapies for ≥ 3 months prior to screening and intends to continue through duration of study.
• Confirmation has been made that the participant is able to obtain the prescribed non hormonal therapy (e.g., insurance coverage verified, participant has ability to self pay, or patient support program activated for at least 12 months for the uninsured participants, if applicable).

Exclusion Criteria

• Participant is currently enrolled in any interventional or non-interventional wearable device study.
• Participant has any condition which makes the participant unsuitable for the study.
• Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
• Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
• Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
• Participant is currently pregnant or planning to become pregnant.
• Participant is post-menopausal and has a history of unexplained uterine bleeding within the last 6 months.
• Participant has pre-existing uncontrolled thyroid disease.
• Participant has unstable angina or participant has uncontrolled hypertension based on a standard of care assessment.

• Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
• Participants with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
• Participant has had insomnia unrelated to either menopause or bothersome VMS due to/associated with menopause.
• Participant has known substance abuse or alcohol addiction within 6 months of screening.
• Participant has been on intramuscular estradiol within 8 weeks of screening.
• Participant has a current diagnosis of a malignancy or history of a malignancy within the past 2 years (This does not include basal cell carcinoma or breast cancer.)
• Participants with metastatic (Stage 4) breast cancer.
• Participants who have been prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors with or without gonadotropin-releasing hormone analogues) for their non-metastatic (stage 0 to 3) breast cancer but have not maintained a stable treatment regimen for at least 3 months prior to screening.
• Participant has initiated hormone pellet therapy within 6 months of screening.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

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

Countries

United States

Other Identifiers

2693-MA-3457

Identifier Type: -

Identifier Source: org_study_id