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

Part of paid clinical trials in Newark, Delaware.

Sponsor
University of Delaware
Study ID
NCT06745466
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Estrogen
  • Premenopause

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • ganirelix acetate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 15, 2024
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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 Outcome Measure

Endothelium-dependent dilation (EDD) [ Time Frame: Immediately before and after each 10-day measurement burst ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of DelawareNewarkDelaware19713
Jody Greaney, PhD
[email protected]
302-831-3181
Virginia Nuckols, PhD
[email protected]
Jody Greaney, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newark, DE

By research site
University of Delaware· Newark, DE