Fezolinetant and Vascular Health and Brain Health
ConditionMenopause Hot Flashes
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorRebecca Thurston
About this trial
The goal of this clinical trial is to learn whether a study drug called fezolinetant impacts cardiovascular and cognitive health in women who have moderate to severe menopausal hot flashes and night sweats.
Researchers will compare fezolinetant to a placebo. A placebo is a pill that looks like the study drug but does not contain any active medicine. This comparison helps researchers understand whether fezolinetant works better than no treatment.
Participants will:
Be randomly assigned to take either fezolinetant (45 mg) or a placebo once a day for 12 weeks.
Visit the research clinic for regular checkups and tests during the study. Complete tests that measure blood vessel function and cognition.
Participants and study staff will not know which treatment each participant receives during the study.
Eligibility criteria
Qualifiers
Born female
Age ≥40 - ≤65 years at the time of the screening visit
Body Mass Index (BMI) ≥18 to ≤38 kg/m2
Seeking treatment or relief for moderate to severe VMS associated with menopause
Disqualifiers
Pregnancy/lactation (past 6 months)
Any treatment for hot flashes with demonstrated efficacy for hot flashes
Currently using systemic sex-hormone medications.
Currently using cytochrome P450 1A2 (CYP1A2) inhibitors (as listed according to the FDA).
Trial design
Treatments tested in this trial
- Placebo
- Fezolinetant
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rebecca Thurston
Lead sponsor
University of Pittsburgh
Sponsor institution
Astellas Pharma Global Development, Inc.
Collaborator
Source ClinicalTrials.gov