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ACTIVE NOT RECRUITING
NCT04037605
EARLY_PHASE1

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction and 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Key Details

Gender

All

Age Range

60 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2020-02-09

Completion Date

2026-06-24

Last Updated

2025-09-11

Healthy Volunteers

Yes

Interventions

DRUG

Ketoconazole Pill (also known as nizoral)

Ketoconazole pill is taken 4 times per inpatient visit

DRUG

Ganirelix

Ganirelix subcutaneous injection is administered twice per inpatient visit

DRUG

Dexamethasone Pill

Dexamethasone pills is taken twice per inpatient visit

DRUG

Dexamethasone injection

Dexamethasone IV injection is given twice per inpatient visit

DRUG

Cosyntropin Injectable Product

Cosyntropin injection is given twice per inpatient visit

DRUG

Recombinant Human Luteinizing Hormone (also known as luveris)

Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit

DRUG

Hydrocortisone Injection (also known as solu-cortef)

Hydrocortisone IV push is given twice per inpatient visit

DRUG

Gonadorelin (also known as Lutrepulse)

Gonadorelin IV injection is given twice per inpatient visit

DRUG

Corticorelin (also known as Acthrel)

Corticorelin IV injection is given twice per inpatient visit

DRUG

Placebo oral tablet

Placebo for Ketoconazole are given 4 times per inpatient visit

DRUG

Saline Solution

Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit

DRUG

Saline solution for injection

Saline Solution (placebo) for ganirelix subcutaneous injection

Locations (1)

Los Angeles Biomedical Research Institute

Torrance, California, United States