NCT06049797

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

A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 999 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-08-06
• Completion: 2026-05-31
• First posted: 2023-09-22
• Last updated: 2026-02-18

Locations

48 sites across 1 country: United States