Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

University of Colorado Denver (CU Denver)

Status and phase: Begins enrollment in 4 months; Phase 3; Phase 2

Conditions: Menopause Related Conditions; Menopause Hot Flashes; Menopause; Cardiovascular

Treatments: Drug: Anti-hypertensives; Drug: Fezolinetant; Drug: Hormonal therapy; Drug: semaglutide; Drug: Lipid Lowering Medication; Drug: Metformin; Behavioral: Life style intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06975111

U1111-1322-1036 (Other Identifier)

25-0943

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 45-55
• In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18
• No current use of hormone therapy or hormonal contraception
• Presence of a uterus and at least one ovary in order to track menstrual patterns
• Have a smartphone and broadband access adequate to accept telehealth appointments

Exclusion criteria

• Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)
• Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.
• Pregnancy or actively trying to get pregnant
• Inability to adhere to study protocol schedule
• Untreated alcoholism
• Un- Diagnosed abnormal uterine bleeding
• Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI> 30 kg/m2.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 5 patient groups

Preventative Health Advice

Experimental group

Description:

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

Treatment:

Behavioral: Life style intervention

Drug: Hormonal therapy

Drug: Fezolinetant

At Risk for Heart Disease

Active Comparator group

Description:

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

Treatment:

Behavioral: Life style intervention

Drug: Metformin

Drug: Lipid Lowering Medication

Drug: Anti-hypertensives

Overweight Women

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: semaglutide

Women with Obesity

Active Comparator group

Description:

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

Treatment:

Drug: semaglutide

Women With Hot Flashes

Active Comparator group

Description:

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

Treatment:

Drug: Hormonal therapy

Drug: Fezolinetant