RightFit
RecruitingPhase 4

Bioenergetic Effects of Aging and Menopause (BEAM)

Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 65 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (1)

CO