A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
(OPTION-VMS Trial)
Recruiting at 50 trial locations
AP
Overseen ByAstellas Pharma Global Development, Inc.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Astellas Pharma Global Development, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This trial is for menopausal women suffering from hot flashes and night sweats. They will use non-hormonal treatments prescribed by their doctors for several months. The study aims to see if these symptoms improve over time and also looks at sleep, work productivity, and overall well-being.
Research Team
CC
Central Contact
Principal Investigator
Astellas Pharma Global Development, Inc.
Eligibility Criteria
Inclusion Criteria
Participants must be diagnosed with bothersome VMS linked to menopause and have been experiencing symptoms for at least three months, as verified by an HCP through a standard of care assessment.
The participant's physical and medical history indicate that they are in a suitable condition to receive treatment with non-hormonal therapies.
The participant must have been taking a stable dose of an SSRI or SNRI for the treatment of anxiety or depression for at least 3 months.
See 3 more
Treatment Details
Participant Groups
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.
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Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Trials
204
Recruited
123,000+
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available
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