NCT04043520 · University of Colorado, Denver
Bioenergetic Effects of Aging and Menopause (BEAM)
(BEAM)
What this study is about
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.
View original scientific description
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
DRUG
GnRH antagonist
GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
DRUG
Estrogen Product
Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
DRUG
Placebo estradiol
Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
DRUG
Placebo GnRH antagonist
Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)
Primary outcome measures
Change in the Microdialysis Cortisone Challenge (MCC) Index
Time frame: Baseline, week 12
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.
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)
Time frame: Baseline, week 12
The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Aurora, Colorado
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2023 · Source of record for eligibility and locations