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RECRUITING
NCT06745466
PHASE4

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

Sponsor: University of Delaware

View on ClinicalTrials.gov

Summary

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 Details

Gender

FEMALE

Age Range

40 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-15

Completion Date

2027-10

Last Updated

2024-12-20

Healthy Volunteers

Yes

Interventions

DRUG

ganirelix acetate

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.

Locations (1)

University of Delaware

Newark, Delaware, United States