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Status:

UNKNOWN

Bioenergetic Effects of Aging and Menopause (BEAM)

Lead Sponsor:

University of Colorado, Denver

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Menopause

Obesity, Abdominal

Eligibility:

FEMALE

40-65 years

Phase:

PHASE4

Brief Summary

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 stud...

Detailed Description

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 stre...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 24 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2024

Estimated Enrollment :

57 Patients enrolled

Trial Details

Trial ID

NCT04043520

Start Date

September 24 2019

End Date

August 31 2024

Last Update

December 18 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States, 80045