protocolSection identificationModule nctId: NCT06264882, orgStudyIdInfo id: 23-1518, secondaryIdInfos id: U54AG062319, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AG062319, briefTitle: Cardiometabolic Consequences of the Loss of Ovarian Function, acronym: LILAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-05-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: 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., conditionsModule conditions: Menopause, conditions: Estrogen Deficiency, conditions: Aging, conditions: Adiposity, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Degarelix, interventions name: Transdermal Estradiol Patch, interventions name: Transdermal Placebo Patch, outcomesModule primaryOutcomes measure: Brachial artery flow mediated dilation (FMD), secondaryOutcomes measure: Visceral fat area (VFA), otherOutcomes measure: Subcutaneous fat area, otherOutcomes measure: Tryptophan-Kynurenine metabolites, otherOutcomes measure: Body composition - mass, otherOutcomes measure: Body composition - bone, otherOutcomes measure: Oxidized LDL, otherOutcomes measure: Total antioxidant status, otherOutcomes measure: Pro-inflammatory cytokines, otherOutcomes measure: Blood lipids and lipoproteins, otherOutcomes measure: Blood glucose, otherOutcomes measure: Insulin, otherOutcomes measure: Adipokines, otherOutcomes measure: Physical activity levels, otherOutcomes measure: Endothelial cell protein measures, otherOutcomes measure: Ex vivo serum exposure studies, otherOutcomes measure: Cerebrovascular function, otherOutcomes measure: Arterial Stiffness, otherOutcomes measure: Carotid artery stiffness, otherOutcomes measure: Blood pressure, otherOutcomes measure: Self reported sleep quality, otherOutcomes measure: Cognitive function, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False