Understanding how stress, sleep, and hormones affect heart health in midlife women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the relationship between estradiol levels, daily stress responses, and sleep variability on vascular function in midlife premenopausal women. It will assess how these factors contribute to cardiovascular disease risk, particularly focusing on the impact of estradiol suppression. Participants will undergo evaluations of their emotional responses to stress and sleep patterns over a period of time, with the goal of identifying potential interventions to improve vascular health. The study will utilize ganirelix acetate as part of its methodology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female
* Age 40-55
* Premenopausal

Exclusion Criteria:

* 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

Where it's running

• University of Delaware
  Newark, Delaware, United States Recruiting

Study contacts

• Principal investigator: Jody Greaney, PhD — University of Delaware
• Study coordinator: Jody Greaney, PhD
• Email: jgreaney@udel.edu
• Phone: 302-831-2193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.