Cardiometabolic Consequences of the Loss of Ovarian Function

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06264882
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Degarelix — DRUG
    After first undergoing a pregnancy test, a clinician will administer an 80-mg subcutaneous injection of degarelix acetate (20 mg/mL; Ferring Pharmaceuticals Inc, Parsippany, NJ) to the women. A second injection will occur at 10 weeks. Compliance to the intervention will be ensured by having participants receive injections in the Clinical and Translational Research Center (CTRC), where all study visits will take place.
  • Transdermal Estradiol Patch — DRUG
    Treatment will be a weekly transdermal patch (0.075 mg) administered in a double-blinded manner. This estradiol dose increases serum estradiol to \~90 pg/mL. Compliance to the intervention will be monitored by having participants keep a log that tracks patch use.
  • Transdermal Placebo Patch — DRUG
    Treatment will be a weekly transdermal patch (placebo inactive) administered in a double-blinded manner. Compliance to the intervention will be monitored by having participants keep a log that tracks patch use.

Study Details

The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.

Key Dates

Start date
Jun 1, 2024
Status verified
Jun 2024
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

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

Arms

  • Experimental: Degarelix plus transdermal placebo
    At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus Placebo transdermal patch (applied twice per week)
  • Experimental: Degarelix plus transdermal estradiol
    At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus 0.075mg estradiol transdermal patch (applied twice per week)

Primary Outcome Measure

Brachial artery flow mediated dilation (FMD) [ Time Frame: Baseline and at 2 and 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Kerrie L Moreau, PhD
[email protected]
303-724-1914

Find similar trials in Aurora, CO

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

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