NCT04037605View on ClinicalTrials.gov

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

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

February 9, 2020

Primary Completion Date

July 24, 2022

Study Completion Date

June 24, 2026

Conditions
Sleep Restriction
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

Trial Locations (1)

90509

Los Angeles Biomedical Research Institute, Torrance

All Listed Sponsors
lead

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER