What is the mechanism of action of this treatment?

Common treatments for menopause include hormonal therapies like estrogen and progestin, which alleviate symptoms such as hot flashes and prevent bone loss by compensating for decreased hormone levels. Non-hormonal treatments, such as SSRIs and gabapentin, modulate neurotransmitters to reduce hot flashes. Cortisol regulation is also crucial, as increased cortisol levels during menopause can lead to abdominal fat accumulation, raising the risk of cardiovascular disease and diabetes. Understanding these mechanisms helps in selecting appropriate treatments to manage symptoms and associated health risks.

What side effects are associated with this type of intervention?

Menopausal Hormone Therapy (MHT), which includes estrogen-only and combined estrogen-progestin treatments, is commonly used to manage menopausal symptoms. Known side effects of MHT include an increased risk of cardiovascular events such as stroke and venous thrombosis, particularly with oral formulations. There is also a potential increased risk of breast cancer with long-term use of combined estrogen-progestin therapy. Additionally, estrogen-only therapy can increase the risk of endometrial hyperplasia and cancer in women with an intact uterus, necessitating the addition of a progestin to mitigate this risk. Other side effects may include weight gain, mood changes, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for menopause, primarily focusing on hormone replacement therapy (HRT). Commonly approved HRT drugs include conjugated estrogens (Premarin), estradiol (Estrace, Climara), and combined estrogen-progestin therapies (Prempro). These treatments help alleviate symptoms like hot flashes, night sweats, and vaginal dryness. Non-hormonal options such as SSRIs (e.g., paroxetine) and SNRIs (e.g., venlafaxine) have also been approved to manage vasomotor symptoms. These therapies aim to balance hormone levels and mitigate the metabolic changes associated with menopause, including weight gain and altered fat distribution.

What other types of research exist?

Promising novel alternatives for cortisol regulation in menopause patients include: 1) Lifestyle modifications such as stress reduction techniques (e.g., mindfulness, yoga), regular physical activity, and a balanced diet. 2) Pharmacological interventions like metformin, which has shown potential in regulating metabolic functions and weight management. 3) Hormonal therapies targeting the hypothalamic-pituitary-adrenal axis to balance cortisol levels. Patients should discuss these options with their healthcare provider to determine the best individualized treatment plan.

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Estrogen Product

Hormone Therapy for Menopause-Related Weight Gain (BEAM Trial)

Phase 4

Recruiting

Led By Wendy M Kohrt, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women will be at least 6 months but not more than 7 years past the last menstrual period (i.e., late perimenopausal or early postmenopausal) with FSH >30 IU/L

Be older than 18 years old

Must not have

Self-reported history of cardiovascular disease

Use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12, week 24

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Summary

This Trial aims to understand how menopause-related hormone changes affect belly fat and disease risk by using treatments to adjust hormone levels in some women.

Who is the study for?

The BEAM study is for healthy peri/postmenopausal women from diverse backgrounds, who are 6 months to 7 years past their last period with specific FSH levels. Excluded are those with abnormal bleeding, on hormone therapy, pregnant or lactating, severe bone loss, liver/thyroid issues, very high BMI or blood pressure, using certain drugs including glucocorticoids and tobacco/THC/alcohol above specified limits.

What is being tested?

This trial investigates if cortisol contributes to belly fat increase during menopause. It involves manipulating hormones in participants by giving them either an estrogen product or a placebo and comparing the effects against those given a GnRH antagonist or its placebo.

What are the potential side effects?

Potential side effects may include reactions related to hormone changes such as mood swings, weight changes, hot flashes and possibly increased risk of blood clots for those susceptible. Specific side effects will depend on the individual's reaction to estrogen products or GnRH antagonists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 6 months to 7 years post-menopause with an FSH level over 30 IU/L.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease.

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I am currently using glucocorticoids or medications affecting glucocorticoid metabolism.

Select...

My liver tests are higher than normal.

Select...

I have severe bone loss with a t-score below -2.0.

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I use marijuana or THC more than three times a week.

Select...

I have had breast cancer or other cancers related to estrogen.

Select...

I have experienced unusual bleeding from my vagina.

Select...

I have had blood clots in my veins or lungs before.

Select...

I am allergic to degarelix, estradiol, or medroxyprogesterone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Microdialysis Cortisone Challenge (MCC) Index

Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)

Secondary study objectives

Change in flow-mediated dilation (FMD)

Change in lumbar spine Bone Mineral Density (BMD)

Change in proximal femur Bone Mineral Density (BMD)

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Postmenopausal: GnRH antagonist + placeboExperimental Treatment2 Interventions

GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo is a transdermal patch, applied weekly for 24 weeks

Group II: Postmenopausal: GnRH antagonist + estradiolExperimental Treatment2 Interventions

GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Estradiol is a transdermal patch 0.075 mg, applied weekly for 24 weeks

Group III: Postmenopausal: placebo + placeboPlacebo Group2 Interventions

Placebo (1) is normal saline, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo (2) is a transdermal patch, applied weekly for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gonadorelin

FDA approved

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for menopause include hormonal therapies like estrogen and progestin, which alleviate symptoms such as hot flashes and prevent bone loss by compensating for decreased hormone levels. Non-hormonal treatments, such as SSRIs and gabapentin, modulate neurotransmitters to reduce hot flashes. Cortisol regulation is also crucial, as increased cortisol levels during menopause can lead to abdominal fat accumulation, raising the risk of cardiovascular disease and diabetes. Understanding these mechanisms helps in selecting appropriate treatments to manage symptoms and associated health risks.

The Utilization of Dehydroepiandrosterone as a Sexual Hormone Precursor in Premenopausal and Postmenopausal Women: An Overview.Dehydroepiandrosterone for women in the peri- or postmenopausal phase.