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Study on Menopause, Estrogen, and Heart Health

This study is looking at how the decrease in estrogen during menopause affects artery health and fat gain, especially around the stomach, which can increase the risk of heart disease. Researchers want to understand if short-term and long-term low estrogen levels in premenopausal women (women who still have regular periods) lead to decreased artery function and increased stomach fat. You would receive injections of Degarelix, a drug that lowers estrogen, and either a Transdermal Estradiol Patch (which contains estrogen) or a Transdermal Placebo Patch (inactive). The main goal is to measure changes in artery health (Brachial artery flow mediated dilation) at the start, and again at 2 and 20 weeks. This study is for women aged 20 to 45 years who have normal menstrual cycles. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 100 women. It uses a double-blinded approach for the patches, meaning neither you nor your doctor will know if you're receiving the active estradiol patch or the placebo.
What's involved
You would undergo a pregnancy test, receive two subcutaneous injections of Degarelix (the second at 10 weeks), and apply a weekly transdermal patch. You would also keep a log to track your patch use.
Compensation
Not stated in the trial record.
Follow-up
Your artery health will be measured at the beginning of the study, and again at 2 and 20 weeks.

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NCT06264882

Cardiometabolic Consequences of the Loss of Ovarian Function

Recruiting
PHASE4Ages 20–45InterventionalBasic science
University of Colorado, Denver
~100 participants
Updated 2024-06-20 on ClinicalTrials.gov
What's tested:DegarelixTransdermal Estradiol PatchTransdermal Placebo Patch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brachial artery flow mediated dilation (FMD)
Measured over Baseline and at 2 and 20 weeks

Conditions

Menopause
Estrogen Deficiency
Aging
Adiposity

Explore related trials

Healthy VolunteersFollicle-Stimulating Hormone

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Kerrie Moreau, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado Denver Anschutz Medical Campus

Who to contact

Kerrie Moreau, PhD
[email protected]
303-724-1914
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age criteria of 20-45 years: the investigators are determining the effects of ovarian suppression on adiposity and vascular in premenopausal women;
Premenopausal defined as normal menstrual cycle function defined as no more than 1 missed cycle in the previous year: irregular menstrual or missed menstrual cycles could indicate that women are anovulatory and/or perimenopause;
Not pregnant or planning to become pregnant;
Not lactating in the last 3 months;
Serum FSH \<10 IU/L measured during days 1-10 of the menstrual cycle: to ensure the woman is premenopausal and not perimenopausal;
Not on hormonal contraception in the last 3 months;
Sedentary or recreationally active (\<2 days/wk vigorous exercise);
No use of medications that might influence vascular function (i.e., antihypertensives, lipid lowering medications, blood thinners);
No use of antioxidant supplements or chronic NSAIDs or be willing to go off them for 4 weeks prior to enrollment in the study;

Exclusion

Diabetic or fasted glucose \>126 mg/dL;
Body mass index (BMI) \>35 kg/m2;
Weight change \>5 kg in the last 3 months;
Use of glucocorticoids (inhaled, oral, topical) or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) in the last 3 months;
Excess alcohol consumption, defined as \>14 drinks per week by self-report;
Known hypersensitivity to study medications;
Depressive symptoms, defined as a CES-D score \>16;
Resting blood pressure \>150/90 mmHg;
Preexisting or active cardiac, renal, or hepatic disease: past or current history of these diseases or conditions;
Active or chronic infection: inflammation associated with active or chronic infections impair vascular function;
Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be reconsidered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
Smoking or Tobacco use within the previous 12 months;
Severe low bone mass or osteoporosis, defined as a hip or lumbar spine T-score \<-2.0: safety reasons, women who are randomized to the ovarian suppression plus placebo group could see a decrease in bone mineral density due to the suppression of estrogen;
History of venous thromboembolic event (VTE): safety reasons, estradiol therapy can increase the risk of VTE;
History of breast cancer or other estrogen-dependent neoplasm: estradiol therapy is contraindicated;

What this trial measures

  • Brachial artery flow mediated dilation (FMD)Baseline and at 2 and 20 weeks

    Ultrasound measurements of brachial artery FMD will be performed in the morning under fasted conditions, and analyzed (Vascular Analysis Tools 5.5.1) according to guidelines. Baseline FMD will be assessed during early follicular phase of menstrual cycle. Blood pressure will be measured prior to the FMD. To confirm endothelial-specific effects of the intervention, the investigators will also measure endothelium-independent dilation as brachial artery dilation to sublingual nitroglycerine (0.4 mg). All ultrasound images will be coded by number and blinded to group assignment.