Cardiometabolic Consequences of the Loss of Ovarian Function

Launched by UNIVERSITY OF COLORADO, DENVER · Feb 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how menopause and lower estrogen levels affect women's artery health and fat gain, particularly in the stomach area. Researchers want to understand whether these changes can lead to an increased risk of heart disease as women age. They will look at how both short-term and long-term low estrogen levels impact artery function and body fat. To do this, they will use a medication to lower estrogen levels and an estrogen patch to see how these changes affect a specific biological process related to aging.

Women aged 20 to 45 who have regular menstrual cycles and are not pregnant or breastfeeding may be eligible to participate. Participants will be monitored over a 20-week period where they may receive either an estrogen patch, a placebo patch (which does not contain estrogen), or a medication to lower estrogen. The study aims to provide valuable insights into how menopause affects women's health. It's important for potential participants to know that there are specific health criteria that must be met to join, and certain medical conditions or medications may disqualify them from participating.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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;