Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
University of Delaware
30 participants
Nov 15, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to identify the impact of estradiol (E2) on the associations between (a) responsivity to daily stress or (b) sleep variability with vascular function in midlife premenopausal women.
Eligibility
Inclusion Criteria3
- Female
- Age 40-55
- Premenopausal
Exclusion Criteria15
- Pregnancy (including a positive urine pregnancy test), planning to become pregnant, or breast-feeding
- Peri- or post-menopausal
- Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease
- Current or lifetime major psychiatric illness (e.g., major depressive disorder, bipolar disorder, schizophrenia, eating disorders)
- History of hysterectomy (complete or partial), polycystic ovary syndrome, endometrial hyperplasia, irregular menstrual cycles, or endometrial ablation
- Suspected potential presence of obstructive sleep apnea (STOP-Bang score >3) or insomnia (Insomnia Severity Index score >15)
- Current or recent (within 8 wks) use of medications that could conceivably alter cardiovascular function or sleep health
- Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication)
- Body mass index >35 kg/m2
- Tobacco or nicotine use, including vaping and electronic cigarettes
- Working night-time or rotating shift work within the previous 3 months
- Trans-meridian travel during study enrollment (inclusive of the entire duration of enrollment and the period between testing cycles)
- Known allergies to pharmacological agents/drugs
- Current use of long-acting reversible contraception (LARC; e.g., IUDs, birth control implants)
- Known latex allergy
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Interventions
Ganirelix acetate (Antagon) will be used to prevent endogenous production of ovarian hormones in young women. Ganirelix is derived from native GnRH, and acts by competitively blocking GnRH receptors on the pituitary and subsequent pathways. Thus, administration of the GnRH antagonist (GnRHant) suppresses steroidogenesis, leading to low or undetectable serum estrogen and progesterone concentrations, which occurs within two days of initiation of administration. Women will self-administer subcutaneous injections (0.25 mg/day in 0.5 ml of normal saline) of the GnRH antagonist ganirelix acetate (Antagon, Organon, Inc., West Orange, New Jersey,) every day for \~12-15 days (starting on day \~2-4 of the menstrual cycle). Testing will occur on day 3-4 and day14-15 of using Antagon.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06745466