Midlife Women's heart health: stress and sleep may be key

NCT ID NCT06745466

Knowledge-focused Sponsor: University of Delaware Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study looks at how daily stress, sleep patterns, and the hormone estrogen affect blood vessel health in women aged 40–55 who are still premenopausal. Researchers will temporarily lower estrogen in 30 volunteers using a drug called ganirelix to see how it changes blood vessel function. The goal is to understand why heart disease risk rises after menopause.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ganirelix acetate
What this could lead to: If successful, this could clarify how estrogen loss during menopause contributes to heart disease risk, pointing toward future prevention strategies.
What could go wrong: This is a small, early-stage mechanistic study (30 participants) that temporarily blocks hormones—it is not testing a treatment. Results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 55 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen Premenopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

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Midlife Women's heart health: stress and sleep may be key

What the study statuses mean