Actively Recruiting
Cardiometabolic Consequences of the Loss of Ovarian Function
Led by University of Colorado, Denver · Updated on 2024-06-20
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how the decrease in estrogen during menopause affects artery health, body fat distribution, and disease risk in women as they age. The study focuses on whether low estrogen levels reduce artery function and increase abdominal fat, and explores the role of a pathway that breaks down tryptophan, an amino acid linked to aging. Researchers will study these effects particularly in premenopausal women by controlling estrogen levels through medication. Participants will be randomly assigned to one of two groups: one receiving degarelix acetate injections plus a placebo patch, and the other receiving degarelix acetate injections plus an estradiol patch. The patches are applied twice per week, and the injections occur at baseline and again at 10 weeks. Additionally, participants will take medroxyprogesterone acetate for 12 days at weeks 9 and 17 to prevent certain uterine changes. The intervention period lasts 20 weeks, during which estrogen levels are carefully controlled and monitored. Participants will undergo assessments of artery function and body fat at baseline, 2 weeks, and 20 weeks, including measurements of brachial artery flow-mediated dilation and visceral fat area. Compliance is tracked by clinical administration of injections and participant logs for patch use. The study also monitors vascular cells and fat tissue to investigate biochemical pathways related to aging and fat accumulation. Women will remain on their assigned treatments until all testing is complete, with ongoing monitoring to evaluate the impact of estrogen changes on cardiovascular and metabolic health.
CONDITIONS
Brief Title
Cardiometabolic Consequences of the Loss of Ovarian Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 to 45 years
- Premenopausal with normal menstrual cycles (no more than 1 missed cycle in the past year)
- Not pregnant and not planning to become pregnant
- Not lactating in the last 3 months
- Serum FSH less than 10 IU/L during days 1-10 of menstrual cycle
- Not using hormonal contraception in the last 3 months
- Sedentary or recreationally active with less than 2 days per week of vigorous exercise
- No use of medications affecting vascular function (e.g., antihypertensives, lipid-lowering drugs, blood thinners)
- No use of antioxidant supplements or chronic NSAIDs, or willing to stop them 4 weeks before enrollment
You will not qualify if you...
- Diabetes or fasting glucose over 126 mg/dL
- Body mass index (BMI) over 35 kg/m2
- Weight change greater than 5 kg in the last 3 months
- Use of glucocorticoids or drugs affecting their metabolism in the last 3 months
- Excess alcohol intake (more than 14 drinks per week)
- Known allergy to study medications
- Depressive symptoms with CES-D score over 16
- Resting blood pressure above 150/90 mmHg
- History of cardiac, kidney, or liver disease
- Active or chronic infections
- Thyroid dysfunction with abnormal TSH levels
- Smoking or tobacco use in the past 12 months
- Severe low bone density or osteoporosis (hip or spine T-score below -2.0)
- History of blood clots
- History of breast cancer or other estrogen-dependent tumors
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Duration - 20 weeks
Participants receive an 80-mg subcutaneous injection of degarelix acetate at baseline and 10 weeks, and wear a weekly transdermal patch (either estradiol or placebo) applied twice per week. At weeks 9 and 17, participants receive medroxyprogesterone acetate for 12 days to prevent endometrial hyperplasia. Outcomes are assessed before treatment and at 2 and 20 weeks during treatment.
Visits at baseline, 2 weeks, 9 weeks, 10 weeks, 17 weeks, and 20 weeks for injections, patch changes, medication administration, and outcome assessments
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
K
Kerrie Moreau, PhD
C
Claire Cox, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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