Multiple Interventions for Menopause

Overseen By Nalia Naushad

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Untreated alcoholism, Abnormal bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

200 Participants Needed

Trial Summary

What is the purpose of this trial?

What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.

Research Team

Nanette Santoro, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for mid-life women experiencing menopause, particularly those with hot flashes and increased risk of heart or metabolic diseases. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to be included.

Inclusion Criteria

Have a smartphone and broadband access adequate to accept telehealth appointments

I have a uterus and at least one ovary.

I am between 45 and 55 years old.

Exclusion Criteria

Pregnancy or actively trying to get pregnant

Inability to adhere to study protocol schedule

Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various interventions including preventative health advice, medications for heart disease risk, insulin resistance, weight loss, and hot flash management

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measurements of epigenetic aging, inflammatory markers, and quality of life

4-8 weeks

Treatment Details

Interventions

• Anti-hypertensives
• Fezolinetant
• Hormonal Therapy
• Lifestyle Intervention
• Lipid Lowering Medication
• Metformin
• Semaglutide

Trial Overview The study tests a range of treatments including semaglutide, metformin (for blood sugar control), anti-hypertensives (for high blood pressure), lipid-lowering medications (for cholesterol), lifestyle changes, Fezolinetant and hormonal therapy to improve women's health during menopause.

Participant Groups

Group I: Preventative Health Advice Experimental Treatment 3 Interventions

Participants will be given preventative health advice and asked to wear an activity \& sleep monitor.

Group II: At Risk for Heart Disease Active Control 4 Interventions

Medications will be given to each participant in this arm that lowers your heart disease risk.

Group III: Overweight Women Active Control 2 Interventions

Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.

Group IV: Women with Obesity Active Control 1 Intervention

Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist.

Group V: Women With Hot Flashes Active Control 2 Interventions

Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+