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

Conditions

• Hot Flashes

Eligibility Criteria

Sex

FEMALE

Age

40 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Fezolinetant — DRUG
  Oral
• Paroxetine — DRUG
  Oral
• Citalopram — DRUG
  Oral
• Escitalopram — DRUG
  Oral
• Desvenlafaxine — DRUG
  Oral
• Venlafaxine — DRUG
  Oral
• Gabapentin — DRUG
  Oral
• Clonidine — DRUG
  Oral
• Pregabalin — DRUG
  Oral
• Oxybutynin — DRUG
  Oral
• Any other SSRI/SNRI not already specified — DRUG
  Oral
• Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above — DRUG
  Oral

Study Details

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.

Key Dates

First listed

Sep 22, 2023

Start date

Nov 15, 2023

Status verified

May 2026

Primary completion

Sep 6, 2025

Completion

May 7, 2026

Study Design

Enrollment

999 participants (actual)

Arms

• Arm: Neurokinin 3 Receptor (NK3-R) Antagonist
  Participants prescribed NK3-R Antagonist for the treatment of VMS.
• Arm: Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)
  Participants prescribed SSRI/SNRI for the treatment of VMS.
• Arm: Other
  Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.

Primary Outcome Measure

Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score [ Time Frame: Baseline and week 12 ]

Locations (48)

Find similar trials in Birmingham, AL

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