Bioenergetic Effects of Aging and Menopause (BEAM) (NCT04043520) | Clinical Trial Compass
UnknownPhase 4
Bioenergetic Effects of Aging and Menopause (BEAM)
United States57 participantsStarted 2019-09-24
Plain-language summary
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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
What they're measuring
1
Change in the Microdialysis Cortisone Challenge (MCC) Index
Timeframe: Baseline, week 12
2
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)