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Trial · Interventional

RecruitingPhase 4Registry data

Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women

Short name V-RISES

NCTNCT06745466 (opens ClinicalTrials.gov in a new tab)Other id2207199Other idR21AG090810
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
University of Delaware · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
15 Nov 2024
Primary completion
31 Oct 2026 (estimated)
Completion
Oct 2027 (estimated)
First posted
20 Dec 2024
Last update posted
2 Jul 2026
Conditions
Estrogen · Premenopause

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 4

    V-RISES

    NCT06745466

    15 Nov 2024 to est. Oct 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ganirelix acetateDrug

Arms2

  • No intervention

    Natural cycle

    Participants will undergo study measurements during the follicular phase of their natural menstrual cycle.

  • Experimental

    No to Low Endogenous Estrogen

    Participants will undergo study measurements during 10 days of daily ganirelix acetate (Antagon) injections.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Endothelium-dependent dilation (EDD)

    Time frame · Immediately before and after each 10-day measurement burst

    Registry description

    EDD will be calculated as the area under the dose-response curve (AUC) to ascending concentrations of acetylcholine.

  2. Negative affective response to daily stressors

    Time frame · 10-day measurement burst

    Registry description

    Within-person composite slope between daily stressors and daily negative affect

  3. Sleep variability

    Time frame · 10-day measurement burst

    Registry description

    Sleep onset standard deviation (minutes) estimated via actigraphy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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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