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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, week 24
Awards & highlights

BEAM Trial Summary

This trial is studying how menopause affects weight gain and risk for diseases like cardiovascular disease and diabetes.

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.Check my eligibility
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.See study design
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.

BEAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 6 months to 7 years post-menopause with an FSH level over 30 IU/L.

BEAM Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Microdialysis Cortisone Challenge (MCC) Index
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)
Secondary outcome measures
Change in flow-mediated dilation (FMD)
Change in lumbar spine Bone Mineral Density (BMD)
Change in proximal femur Bone Mineral Density (BMD)
+2 more

BEAM 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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,469 Total Patients Enrolled
10 Trials studying Menopause
656 Patients Enrolled for Menopause
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,868 Total Patients Enrolled
16 Trials studying Menopause
3,156 Patients Enrolled for Menopause
Wendy M Kohrt, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
109 Total Patients Enrolled

Media Library

Estrogen Product (Estrogen Product) Clinical Trial Eligibility Overview. Trial Name: NCT04043520 — Phase 4
Menopause Research Study Groups: Postmenopausal: GnRH antagonist + placebo, Postmenopausal: placebo + placebo, Postmenopausal: GnRH antagonist + estradiol
Menopause Clinical Trial 2023: Estrogen Product Highlights & Side Effects. Trial Name: NCT04043520 — Phase 4
Estrogen Product (Estrogen Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04043520 — Phase 4
Menopause Patient Testimony for trial: Trial Name: NCT04043520 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an overview of prior investigations surrounding Estrogen Product?

"Presently, there are 120 trials analyzing Estrogen Product with 25 of those currently in their final phase. The majority are situated in Duarte California but the medication is being tested at 3485 different sites around the world."

Answered by AI

To what degree can Estrogen Product be deleterious to patients?

"Estrogen Product has been approved, which is reflected in its score of 3 for safety."

Answered by AI

What is the total recruitment capacity for this clinical trial?

"That is correct. According to information hosted on clinicaltrials.gov, the trial was first launched in September 2019 and has since been actively recruiting patients for participation. A total of 57 participants are sought at a single medical centre."

Answered by AI

To whom is the opportunity to participate in this clinical trial offered?

"This clinical trial necessitates that applicants be between 40 and 65 years old, suffer from obesity, and have visceral fat to qualify. The research is hoping to accrue a total of 57 participants."

Answered by AI

What medical maladies is Estrogen Product commonly administered to alleviate?

"Estrogen Product is commonly employed to treat women with no menstrual period in the past 6 months, as well as hypoestrogenism, vasomotor symptoms related to menopause, and breast cancer."

Answered by AI

Are any new participants being accepted into this experiment at present?

"Affirmative. According to clinicaltrials.gov, the research is actively seeking participants and was originally published on September 24th 2019 before being modified lastly on October 19th 2022. 57 individuals from a single study location are required for this medical trial."

Answered by AI

What positive outcomes is this trial hoping to manifest?

"This medical trial, to be assessed over a Baseline and week 12 time period, intends to determine the alteration in Oral Cortisone Challenge (OCC) Area Under the Curve (AUC). Secondary goals include an evaluation of deviation in resting energy expenditure (REE), flow-mediated dilation (FMD), as well as visceral fat area (VFA). REE is an index of metabolism while at rest; conversely FMD measures vascular health. Finally VFA elucidates how much fat is stored within the abdominal region."

Answered by AI

Does this clinical trial permit elderly individuals to participate?

"As laid out by the inclusion criteria for this trial, patients between 40 and 65 years old are eligible. Conversely, there are 33 studies targeting those under 18 while 362 trials offer assistance to people beyond retirement age."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
University of Colorado - Anschutz Medical Campus

Why did patients apply to this trial?

I have tired3 other drugs and nothing I am hoping that this trial will help me so I can help others.
PatientReceived 2+ prior treatments
~4 spots leftby Aug 2024