Recruiting nowPhase 4Interventional
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age40 Years to 65 Years
SexFemale
Healthy volunteersAccepted
ConditionMenopause, Obesity, Abdominal, Aging, Weight Gain
Full registry criteria
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
Treatments and study arms
GnRH antagonist
Drug
GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
Estrogen Product
Drug
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).
Placebo estradiol
Drug
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).
Placebo GnRH antagonist
Drug
Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)
