Finding Links Between Hot flASHes and CardioVascular Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07077395
Phase
PHASE2
Status
Recruiting

Conditions

  • Menopause-related Hot Flashes

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • elinzanetant - reference formulation — DRUG
    elinzanetant 120 mg daily x 12 weeks
  • placebo — DRUG
    placebo daily x 12 weeks

Study Details

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?

Key Dates

Start date
Mar 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: elinzanetant 120 mg daily for 12 weeks
  • Placebo Comparator: Placebo daily for 12 weeks

Primary Outcome Measure

brachial artery flow mediated dilation [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Kamila Bielawski
617-643-6161
Massachusetts General HospitalBostonMassachusetts02114
Kamila Bielawski
617-724-3064

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