NCT04043520RecruitingPhase 4
Bioenergetic Effects of Aging and Menopause (BEAM)
Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018
Source: ClinicalTrials.gov · Last updated 18 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- First submitted
- 25 Jun 2019
- Start date
- 24 Sept 2019
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity
- NCT number
- NCT04043520
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 57
- From 24 Sept 2019 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- on hormonal contraceptive or menopausal therapy or intention to start during the period of study
- use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole)
Other illness
- abnormal vaginal bleeding
- known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate
- 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
Lab values
- liver dysfunction, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal
Other
- positive pregnancy test or intention to become pregnant during the period of study
- lactation
- 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
- 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
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.