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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

Quick Stats
Studies 172
Trials 37
Active Not Recruiting PHASE1 INTERVENTIONAL NCT03142893

Hormonal Mechanisms of Sleep Restriction - Axis Study

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 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.

Detailed Description

Sleep restriction increases evening cortisol and decreases testosterone. These are the main catabolic and anabolic hormones in men, respectively. This catabolic-anabolic imbalance likely leads to metabolic and reproductive ill-health. The hypothalamic-pituitary-end organ (adrenal or testis) mechanisms that must underpin these changes are unknown. This study will administer drugs to clamp the function of each of these nodes to determine the regulatory changes that have occurred with sleep restriction. Even though the study is randomized order in design, the main comparison is before and after sleep restriction under each of these clamp conditions. Participants are admitted to the chronobiology laboratory where they are given 1 night of 10 hours sleep opportunity, followed by 4 nights of 4 hours sleep opportunity. Up to 80 participants (assuming twenty different participant for each of the 4 clamp conditions) can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 20 participants may be required. Urn randomization will be used to ensure that 20 different participants are involved in each of the 4 conditions.

Interventions

Name: Ketoconazole Pill
Type: DRUG
Description: Ketoconazole pill is taken 4 times per Inpatient Stay
Name: Ganirelix
Type: DRUG
Description: Ganirelix subcutaneous injection is administered twice per Inpatient Stay
Name: Dexamethasone
Type: DRUG
Description: Dexamethasone Pills is taken twice per Inpatient Stay
Name: Dexamethasone Injection
Type: DRUG
Description: Dexamethasone IV injection is given twice per Inpatient Stay
Name: Cosyntropin Injectable Product
Type: DRUG
Description: cosyntropin injection is given twice per Inpatient Stay
Name: Recombinant Human Luteinizing Hormone
Type: DRUG
Description: Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit
Name: Hydrocortisone Injection
Type: DRUG
Description: Hydrocortisone IV push is given twice per Inpatient Visit
Name: Gonadorelin
Type: DRUG
Description: Gonadorelin IV injection is given twice per Inpatient Stay
Name: Corticorelin
Type: DRUG
Description: Corticorelin IV injection is given twice per Inpatient Stay
Name: Placebo oral capsule
Type: DRUG
Description: Placebo for ketoconazole are given 4 times per Inpatient Stay
Name: Saline Solution
Type: DRUG
Description: Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per Inpatient Stay
Name: Saline Solution for Injection
Type: DRUG
Description: Saline Solution (placebo) for ganirelix subcutaneous injection

Primary Outcomes

Measure: Average Blood Cortisol Concentration
TimeFrame: 5 days
Description: Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.
Measure: Average Blood Testosterone Concentration
TimeFrame: 5 days
Description: Testosterone is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.

Trial Information

NCT ID

NCT03142893

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Peter y. Liu

Last Updated

December 15, 2025