Taking people in United StatesPhase 4

Tests how hormone changes at menopause affect weight and belly fat

Studies whether the stress hormone cortisol drives belly fat gain in women after menopause.

Key facts

Who runs it: University of Colorado, Denver
Where: Aurora, United StatesSee the site
Trial code: NCT04043520
Registry title: Bioenergetic Effects of Aging and Menopause (BEAM)
Status: Recruiting
Phase: Phase 4
People taking part: 57 people, planned
Started: 24 Sept 2019
Planned end: 31 Aug 2024
Type of study: Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: GnRH antagonist
Estrogen Product
Placebo estradiol
Placebo GnRH antagonist
Record updated: 18 December 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy women who are late in the menopause transition or recently past it, and who are willing to have their hormones changed during the study.

Age: 40 to 65 years
Sex: Women only
Disease stage: At least 6 months but not more than 7 years since the last period, with an FSH level above 30 IU/L.
Earlier treatment: Cannot be on hormonal birth control or menopause hormone therapy, or plan to start it during the study.
Biomarker or test result: FSH above 30 IU/L.

Main reasons for not taking part

Abnormal vaginal bleeding
Positive pregnancy test, planned pregnancy or breastfeeding
BMI above 39 kg/m2
History of breast cancer, blood clots or cardiovascular disease
Severe osteoporosis, thyroid or liver problems, or uncontrolled high blood pressure

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

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

Who cannot take part

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)
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
liver dysfunction, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 40 and 65 years old?

Where in United States

University of Colorado Anschutz Medical CampusAurora, United StatesContact: Wendy M Kohrt, PhDTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Postmenopausal: GnRH antagonist + estradiolTreatment being tested
GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Estradiol is a transdermal patch 0.075 mg, applied weekly for 24 weeks
Treatment: GnRH antagonist and Estrogen Product
Postmenopausal: GnRH antagonist + placeboTreatment being tested
GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo is a transdermal patch, applied weekly for 24 weeks
Treatment: GnRH antagonist and Placebo estradiol
Postmenopausal: placebo + placeboPlacebo, for comparison
Placebo (1) is normal saline, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo (2) is a transdermal patch, applied weekly for 24 weeks
Treatment: Placebo estradiol and Placebo GnRH antagonist