Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT06745466
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT06745466
Study Brief:
Protocol Section:
NCT06745466