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Trial · Interventional

RecruitingPhase 4Registry data

Bioenergetic Effects of Aging and Menopause (BEAM)

Short name BEAM

NCTNCT04043520 (opens ClinicalTrials.gov in a new tab)Other id18-2483Other idU54AG062319

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
57 participants (estimated)
Sponsor
University of Colorado, Denver · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
24 Sept 2019
Primary completion
31 Aug 2024 (estimated)
Completion
31 Aug 2024 (estimated)
First posted
2 Aug 2019
Last update posted
18 Dec 2023
Conditions
Menopause · Obesity, Abdominal · Aging · Weight Gain

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022202320242025
  1. Ph 4

    BEAM

    NCT04043520

    24 Sept 2019 to est. 31 Aug 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift.

Interventions

  • GnRH antagonistDrug
  • Estrogen ProductDrug
  • Placebo estradiolDrug
  • Placebo GnRH antagonistDrug

Arms3

  • Experimental

    Postmenopausal: GnRH antagonist + estradiol

    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

  • Experimental

    Postmenopausal: GnRH antagonist + placebo

    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

  • Placebo comparator

    Postmenopausal: placebo + placebo

    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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in the Microdialysis Cortisone Challenge (MCC) Index

    Time frame · Baseline, week 12

    Registry description

    The MCC Index is an in vivo measurement of local cortisol production in abdominal adipose tissue. A higher MCC Index is an indicator of more local cortisol production.

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

    Time frame · Baseline, week 12

    Registry description

    The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol.

Secondary outcomes(5)
  1. Change in lumbar spine Bone Mineral Density (BMD)

    Time frame · Baseline, week 24

    Registry description

    Lumbar spine BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis.

  2. Change in resting energy expenditure (REE)

    Time frame · Baseline, week 12, week 24

    Registry description

    REE is an index of metabolic rate at rest, measured by indirect calorimetry. A higher REE is an indicator of greater energy expenditure at rest.

  3. Change in visceral fat area (VFA)

    Time frame · Baseline, week 24

    Registry description

    VFA of the abdominal visceral region is measured by computed tomography. VFA is an indicator of the amount of fat stored in this region.

  4. Change in flow-mediated dilation (FMD)

    Time frame · Baseline, week 12, week 24

    Registry description

    FMD of the brachial artery as an index of vascular function. A higher number is a general indicator of better vascular function.

  5. Change in proximal femur Bone Mineral Density (BMD)

    Time frame · Baseline, week 24

    Registry description

    Proximal femur BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures. 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. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels. Women will be excluded for the reasons listed below. Exclusion Criteria: * abnormal vaginal bleeding * on hormonal contraceptive or menopausal therapy or intention to start during the period of study * positive pregnancy test or intention to become pregnant during the period of study * lactation * known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate * Center for Epidemiological Studies Depression Scale (CES-D) score \<,16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart) * current tobacco and/or vape use more than 2 times/week * current marijuana or tetrahydrocannabinol (THC) use in any form more than 3 times/week * regular self-reported alcohol consumption \>14 drinks/week * BMI \>39 kg/m2 * use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) * severe osteopenia or osteoporosis, defined as femoral neck or lumbar spine t-score \<-2.0 * thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement * liver dysfunction, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal * uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care provider (PCP) with initiation or adjustment of anti-hypertensive medications * self-reported history of breast cancer or other estrogen-dependent neoplasms * self-reported history of venous thromboembolism, pulmonary embolism, or other thromboembolic disorder * self-reported history of cardiovascular disease

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