Bioenergetic Effects of Aging and Menopause (BEAM)
Recruiting
Phase 4Interventional Study
MenopauseObesity, AbdominalAgingWeight Gain
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 65
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
57 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 postmenop…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.