NCT03142893View on ClinicalTrials.gov

Hormonal Mechanisms of Sleep Restriction - Axis Study

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

May 8, 2017

Primary Completion Date

October 30, 2020

Study Completion Date

June 30, 2026

Conditions
Sleep Restriction
Interventions
DRUG

Ketoconazole Pill

Ketoconazole pill is taken 4 times per Inpatient Stay

DRUG

Ganirelix

Ganirelix subcutaneous injection is administered twice per Inpatient Stay

DRUG

Dexamethasone

Dexamethasone Pills is taken twice per Inpatient Stay

DRUG

Dexamethasone Injection

Dexamethasone IV injection is given twice per Inpatient Stay

DRUG

Cosyntropin Injectable Product

cosyntropin injection is given twice per Inpatient Stay

DRUG

Recombinant Human Luteinizing Hormone

Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit

DRUG

Hydrocortisone Injection

Hydrocortisone IV push is given twice per Inpatient Visit

DRUG

Gonadorelin

Gonadorelin IV injection is given twice per Inpatient Stay

DRUG

Corticorelin

Corticorelin IV injection is given twice per Inpatient Stay

DRUG

Placebo oral capsule

Placebo for ketoconazole are given 4 times per Inpatient Stay

DRUG

Saline Solution

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

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

Peter y. Liu

OTHER