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New treatment option for Menopause-related Hot Flashes
Official title Finding Links Between Hot flASHes and CardioVascular Disease
ClinicalTrials.gov ID: NCT07077395
What this study is testing
What is elinzanetant - reference formulation?
elinzanetant - reference formulation is an investigational medicine, given as an once-daily, being studied as a potential treatment for menopause-related hot flashes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, women only
You may be able to join if
- Age 40-65 years
- Peri- and post-menopausal women (STRAW -1 to +1)
- Moderate or high vasmotor symptom burden
- Cardiometabolic disease (as evidenced by ≥ 2 of the following):
- Obesity (body mass index ≥ 30 kg/m2)
You likely can't join if
- 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)
- Undiagnosed uterine bleeding over past 6 months
See the full eligibility criteria
- Age 40-65 years
- Peri- and post-menopausal women (STRAW -1 to +1)
- Moderate or high vasmotor symptom burden
- Cardiometabolic disease (as evidenced by ≥ 2 of the following):
- Obesity (body mass index ≥ 30 kg/m2)
- Elevated waist circumference (≥ 88 cm)
- Elevated triglycerides (≥ 150 mg/dL or drug treatment)
- Reduced HDL-cholesterol (\<50 mg/dL or drug treatment)
- Elevated blood pressure (≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure, or drug treatment)
- Elevated fasting glucose (≥ 100 mg/dL or drug treatment)
- 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)
- Undiagnosed uterine bleeding over past 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.