Fezolinetant and Vascular Health and Brain Health
Rebecca Thurston
Summary
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.
Description
Double-blind, placebo-controlled randomized trial to determine whether 12 weeks of 45 mg of fezolinetant, a non-hormonal treatment for hot flashes associated with menopause, improves vascular and brain health in participants with moderate to severe menopausal hot flashes. Participants will be randomized to either 12 weeks of fezolinetant 45 mg or placebo. Primary endpoints include change from baseline in endothelial function and verbal memory.
Eligibility
- Age range
- 40–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Confirmed menopausal as per one of the following criteria at the time of screening: Reporting spontaneous amenorrhea for ≥12 consecutive months; spontaneous amenorrhea for ≥6 and \< 12 months with follicle-stimulating hormone \>40 IU/L * Negative urine pregnancy test at screening (if \<12 months of amenorrhea) * A minimum average of 7-8 moderate to severe VMS per day, or 50-60 pe…
Interventions
- DrugPlacebo
The placebo tablet will be an identical tablet appearing to active medication. The placebo tablets contain the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide).
- DrugFezolinetant
Fezolinetant is a white powder. It is very slightly soluble in water (0.29 mg/mL). Fezolinetant tablets that will be used in this study are round, light red film-coated tablets with no marking on the tablets. Each fezolinetant tablet for oral use contains 45 mg of fezolinetant and the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
Locations (2)
- University of Illinois, ChicagoChicago, Illinois
- University of PittsburghPittsburgh, Pennsylvania