Finding Links Between Hot flASHes and CardioVascular Disease

ConditionMenopause-related Hot Flashes

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age40-65

SponsorMassachusetts General Hospital

About this trial

The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-65 years

Peri- and post-menopausal women (STRAW -1 to +1)

Moderate or high vasmotor symptom burden

Obesity (body mass index ≥ 30 kg/m2)

Disqualifiers

Inability to provide informed consent or comply with study protocol

Major comorbidities: cancer, end-stage renal (eGFR <45 mL/min/1.73 m2), liver or lung disease

Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors

Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)

Trial design

Design model

Parallel

Treatments tested in this trial

elinzanetant - reference formulation
Drug
elinzanetant 120 mg daily x 12 weeks
placebo
Drug
placebo daily x 12 weeks

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: elinzanetant 120 mg daily for 12 weeksActive comparator 1 intervention

Group B: Placebo daily for 12 weeksPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

brachial artery flow mediated dilation

Time frame

12 weeks

Secondary outcomes

concentration of inflammatory protein biomarkers

* General inflammatory markers: hsCRP, IL-8, TNF-ɑ/β * Leukocyte adhesion markers: MCP-1, ICAM-1 * Markers of vascular homeostasis: ANGPT1, VEGFA, HB-EGF

Time frame

12 weeks

Sponsors and contacts

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

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now