Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    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).

  • Fezolinetant

    Drug

    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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Placebo ArmPlacebo comparator 1 intervention
Group B: Active Study DrugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Flow-Mediated Dilation

Endothelial function assessed by flow-mediated dilation

Time frame
Baseline and end of treatment at 12 weeks.
2

Verbal Memory Performance

Verbal memory performance on the California Verbal Learning Test

Time frame
Baseline and end of treatment at 12 weeks.

Secondary outcomes

1

Endothelial Biomarkers

Blood-based endothelial function biomarkers

Time frame
Baseline and end of treatment at 12 weeks.
2

Brain Activation during Verbal Encoding

Memory circuitry as measured by changes in brain activation during performance of a functional magnetic resonance imaging (fMRI) task of verbal encoding

Time frame
Baseline and end of treatment at 12 weeks.
3

Functional Connectivity during recall

Memory circuitry as measured by changes in functional connectivity during performance of a functional magnetic resonance imaging (fMRI) task of verbal recall

Time frame
Baseline and end of treatment at 12 weeks.
4

Subjective Vasomotor Hot Flash Diary

frequency of subjectively assessed VMS using a digital hot flash diary

Time frame
Baseline and end of treatment at 12 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rebecca Thurston

Lead sponsor

University of Pittsburgh

Sponsor institution

Astellas Pharma Global Development, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: