Health TrialsbyHealthPanel

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

ConditionsEstrogenPremenopause
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorUniversity of Delaware

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female

Age 40-55

Premenopausal

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Natural cycleNo intervention 0 interventions
Group B: No to Low Endogenous EstrogenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Endothelium-dependent dilation (EDD)

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

Time frame
Immediately before and after each 10-day measurement burst
2

Negative affective response to daily stressors

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

Time frame
10-day measurement burst
3

Sleep variability

Sleep onset standard deviation (minutes) estimated via actigraphy

Time frame
10-day measurement burst

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Delaware

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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