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 — DRUGelinzanetant 120 mg daily x 12 weeks
- placebo — DRUGplacebo 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
- Kamila Bielawski617-724-3064
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 |