Bioenergetic Effects of Aging and Menopause (BEAM)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04043520
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • GnRH antagonist — DRUG
    GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
  • Estrogen Product — DRUG
    Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
  • Placebo estradiol — DRUG
    Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
  • Placebo GnRH antagonist — DRUG
    Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)

Study Details

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.

Key Dates

First listed
Aug 2, 2019
Start date
Sep 24, 2019
Status verified
Dec 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
57 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Postmenopausal: GnRH antagonist + estradiol
    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
  • Experimental: Postmenopausal: GnRH antagonist + placebo
    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
  • Placebo Comparator: Postmenopausal: placebo + placebo
    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

Primary Outcome Measure

Change in the Microdialysis Cortisone Challenge (MCC) Index [ Time Frame: Baseline, week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado - Anschutz Medical CampusAuroraColorado80045
Wendy M Kohrt, PhD
[email protected]
303-724-1913
Wendy M Kohrt, PhD (PRINCIPAL_INVESTIGATOR)
Margaret Wierman, MD (SUB_INVESTIGATOR)
Daniel Bessesen, MD (SUB_INVESTIGATOR)
Kerrie Moreau, PhD (SUB_INVESTIGATOR)
Edward Melanson, PhD (SUB_INVESTIGATOR)

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By condition
Menopause
By specialty
Women's healthFertility
By research site
University of Colorado - Anschutz Medical Campus· Aurora, CO

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