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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various treatments to help women improve their health and quality of life during menopause. The focus includes reducing inflammation, enhancing heart health, slowing aging, and easing symptoms like hot flashes. Participants will join different groups to test medications for heart disease, weight management, and hormone-related symptoms, along with lifestyle advice. Treatments include anti-hypertensives (for blood pressure), fezolinetant (a potential new drug for menopausal symptoms), hormonal therapy, lifestyle intervention, lipid-lowering medication, metformin (for blood sugar control), and semaglutide (for weight management). Women aged 45-55 experiencing late menopausal transition without current hormone therapy might be suitable candidates. The goal is to find effective ways to enhance health and well-being during and after menopause. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on hormone therapy or hormonal contraception to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that fezolinetant effectively reduces hot flashes in menopausal women and is generally well-tolerated. However, there is a rare risk of serious liver injury, so monitoring liver health is important when considering this treatment.

Research on hormonal therapy has shown it is FDA-approved to treat menopausal symptoms like hot flashes and night sweats. The FDA has removed past warnings about serious risks, indicating confidence in the safety of these treatments when started within ten years of menopause.

Semaglutide, often used for weight loss and diabetes management, has a good safety record. Studies show it aids in weight loss and reduces major heart risks, although specific data on menopausal women is limited.

Metformin, commonly used to manage blood sugar levels, is also considered safe and beneficial for healthy aging, especially in women with insulin resistance or diabetes.

Each of these treatments has been studied and generally shows a good safety profile. Always discuss with a healthcare provider to weigh the benefits and risks for personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for menopause because they offer a multi-faceted approach to managing symptoms and associated health risks. Fezolinetant, a non-hormonal option, targets the brain's temperature regulation, potentially providing relief from hot flashes without the hormone-related risks of traditional therapies. Semaglutide, a GLP-1 antagonist, aids in weight management for women with obesity, which is crucial since excess weight can exacerbate menopausal symptoms and increase heart disease risk. Moreover, lifestyle interventions and medications like Metformin and anti-hypertensives address metabolic health, offering a comprehensive strategy that goes beyond simply managing immediate symptoms. Together, these treatments could redefine menopause care by addressing both symptoms and broader health implications.

What evidence suggests that this trial's treatments could be effective for menopause-related conditions?

Research has shown that several treatments may help with menopause-related issues. In this trial, participants in different arms will receive specific treatments. Fezolinetant, available to participants in the "Women With Hot Flashes" arm, has effectively reduced moderate to severe hot flashes and improved sleep and work productivity for women after menopause. Hormonal therapy, also an option for the "Women With Hot Flashes" arm, can significantly reduce bothersome menopause symptoms and may lower the risk of heart problems. Participants in the "Women with Obesity" arm may receive Semaglutide, which has led to significant weight loss in postmenopausal women, with more than half showing improved body mass index (BMI) after treatment. Each of these treatments has the potential to improve quality of life and address different menopause challenges. ^{3 6 7 8 9}

Who Is on the Research Team?

Nanette Santoro, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10387909/

The effectiveness and value of fezolinetant for moderate- ... Pooled data from the Skylight trials reported that fezolinetant significantly improved scores on the Menopause Quality of Life Questionnaire (MENQoL) compared ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224002548

Effect of fezolinetant on patient-reported quality-of-life ... Fezolinetant was shown to be efficacious and well tolerated for treating moderate to severe VMS associated with menopause in phase 3 studies, SKYLIGHT 1 and ...

3. bmj.com bmj.com/content/387/bmj-2024-079525

Efficacy and safety of fezolinetant for moderate-severe ... Conclusions Fezolinetant was efficacious and well tolerated over a six month period for treating moderate-severe vasomotor symptoms in ...

4. contemporaryobgyn.net contemporaryobgyn.net/view/fezolinetant-shows-significant-real-world-improvements-in-vasomotor-symptoms-sleep

Fezolinetant shows significant real-world improvements in ... Real-world data show fezolinetant improves vasomotor symptoms, sleep, and work productivity in postmenopausal women.

5. journals.lww.com journals.lww.com/menopausejournal/fulltext/2024/01000/systematic_review_and_network_meta_analysis.11.aspx

Systematic review and network meta-analysis comparing ... Fezolinetant 45 mg once daily was statistically significantly more effective than other non-HTs in reducing the frequency of moderate to severe VMS.

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due

FDA adds warning about rare occurrence of serious liver ... FDA is warning that Veozah (fezolinetant) used to treat moderate to severe hot flashes due to menopause can cause rare but serious liver injury ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39739195/

Safety of Fezolinetant for Treatment of Moderate to Severe ... This study evaluated the safety and tolerability of fezolinetant in women with vasomotor symptoms (VMS) due to menopause in a pooled analysis of data from ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524001921

Effectiveness and safety of fezolinetant in alleviating ... Fezolinetant significantly reduces frequency/severity of menopausal symptoms. · Fezolinetant enhances menopause-specific quality of life scores at 4/12 weeks, ...

9. journals.lww.com journals.lww.com/greenjournal/fulltext/2025/03000/fezolinetant_and_elinzanetant_therapy_for.3.aspx

Fezolinetant and Elinzanetant Therapy for Menopausal ... Elinzanetant 120 mg was associated with the occurrence of drug-related adverse events (11.70% vs 20.75%, risk ratio [RR] 0.57, 95% CI, 0.39–0.82, I 2=19%) and ...