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

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

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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.

  lead INDUSTRY

Principal Investigators

• Central Contact · Astellas Pharma Global Development, Inc.

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-15

Primary Completion

2025-09-06

Completion

2026-05-31

Countries

• United States

Study Locations