← Back to Search

Neurokinin 3 Receptor (NK3-R) Antagonist for Hot Flashes (OPTION-VMS Trial)

N/A
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 8, 12, 24 and 52
Awards & highlights

OPTION-VMS Trial 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.

OPTION-VMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8, 12, 24 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8, 12, 24 and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device
Change from baseline in average daily sleep efficiency, as recorded by wearable device
Change from baseline in average daily sleep latency, as recorded by wearable device
+21 more

OPTION-VMS Trial Design

3Treatment groups
Experimental Treatment
Group I: Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)Experimental Treatment6 Interventions
Participants prescribed SSRI/SNRI for the treatment of VMS.
Group II: OtherExperimental Treatment5 Interventions
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
Group III: Neurokinin 3 Receptor (NK3-R) AntagonistExperimental Treatment1 Intervention
Participants prescribed NK3-R Antagonist for the treatment of VMS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Desvenlafaxine
2022
Completed Phase 4
~3662140
Gabapentin
2013
Completed Phase 4
~1550
Escitalopram
2005
Completed Phase 4
~2330
Citalopram
2010
Completed Phase 4
~3258800
Paroxetine
2002
Completed Phase 4
~3259280
Oxybutynin
2015
Completed Phase 4
~2720
Clonidine
2010
Completed Phase 4
~1890
Venlafaxine
2007
Completed Phase 4
~3259640
Fezolinetant
2020
Completed Phase 3
~1560
Pregabalin
2005
Completed Phase 4
~6110

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,086 Total Patients Enrolled
5 Trials studying Hot Flashes
3,668 Patients Enrolled for Hot Flashes
Central ContactStudy DirectorAstellas Pharma Global Development, Inc.
98 Previous Clinical Trials
6,396,362 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~667 spots leftby Sep 2025