DRUG
Ketoconazole Pill
Ketoconazole pill is taken 4 times per Inpatient Stay
Hormonal Mechanisms of Sleep Restriction - Axis Study
Status
Active, not recruiting
Phase
Phase 1
Enrollment
80
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
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
Timeline
From registration to results.
First posted
May 8, 2017
Study start
May 8, 2017
Primary completion
Oct 30, 2020
Study completion
Jun 30, 2026
Results posted
Not reported
Registry updated
Sep 11, 2025
Outcomes
What the study measures.
Primary outcomes
Average Blood Cortisol Concentration
Time frame · 5 days
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.
Average Blood Testosterone Concentration
Time frame · 5 days
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.
Secondary outcomes
Peak Blood Cortisol Concentration
Time frame · 5 days
This is the single maximal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Peak Blood Testosterone Concentration
Time frame · 5 days
This is the single maximal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Trough Blood Cortisol Concentration
Time frame · 5 days
This is the single minimal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Trough Blood Testosterone Concentration
Time frame · 5 days
This is the single minimal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
Reaction time on Psychomotor Vigilance Task
Time frame · 5 days
This is measured by lapses in attention. As the person becomes more sleepy, there are more lapses (reaction time \>500 ms), at the beginning and at the end of 4 nights of sleep restriction.
Karolinska Sleepiness Scale
Time frame · 5 days
Measures how sleepy participants are using a scale of 1 (extremely alert) through 9. This scale will be used to assess changes in sleepiness throughout the day and through 4 nights of sleep restriction.
Two card gambling task
Time frame · 5 days
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects participants' decision making. The end point is discriminability index, d'.
Modified Sternberg working memory test
Time frame · 5 days
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects reaction time and accuracy.
Caloric Intake
Time frame · 5 days
The food given to participants is weighed. The amount that is not consumed is also weighed. The difference in weight is the amount of calories consumed.
Hunger Scale
Time frame · 5 days
Hunger scale using Flint visual analogue scale to assess how 4 nights of sleep restriction affects participants' appetite.
Eligibility
Who can take part.
- Minimum age
- 22 Years
- Maximum age
- 45 Years
- Sex
- MALE
- Healthy volunteers
- Yes
Inclusion Criteria: * Men aged 22-45 years * Willingness to provide written informed consent * Stable weight over preceding 6 weeks * Body Mass index (BMI) 20-28 kg/m2 Exclusion Criteria: * Unable or unwilling to provide IRB (Internal Review Board)-approved informed consent * Clinical disorders and/or illnesses * Current medical or drug treatment, as assessed by questionnaire * History of brain injury or of learning disability - Vision or hearing impairment unless corrected back to normal * Anemia (Hct \<38%) * History of psychiatric illness * Clinically significant abnormalities in blood and urine, and free of traces of drugs * Other endocrine abnormalities including hypothyroidism or adrenal failure; primary gonadal disease as indicated by serum LH (luteinizing hormone) or FSH (follicle stimulating hormone) concentration \>10 or \>15 IU/L, respectively, hyperprolactinemia indicated by prolactin \>25ug/L * Type 2 Diabetes (HgbA1C) * Current smoker * Recent or concurrent drug or alcohol abuse * Blood donation in previous eight weeks * Travel across time zones within one month of entering the study * Sleep or circadian disorder * Shift work within three months of entering the study * Irregular bedtimes (not between 6 and 10 hours in duration) * Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, Hx or Suspicion of cancer of the prostate gland or PSA (prostate-specific antigen) \>4ng/ml * Previous adverse reaction to sleep deprivation or any of the drugs to be administered * Concurrent participation in another research study
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Los Angeles Biomedical Research Institute
Torrance, California, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Ganirelix.
NCT IDStudyPhase / statusEnrollmentUpdated
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist for Ovarian Stimulation in IVF/ICSI
Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) · Infertility, Female · Ovulation Induction
Early Phase 1
Not yet recruiting
189
2026-07
Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
University of Delaware · Estrogen · Premenopause
Phase 4
Recruiting
30
2026-07
Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?
ART Fertility Clinics LLC · Healthy
Not applicable
Not yet recruiting
20
2026-05
INTEnsity of ovariaN Stimulation and Embryo Quality
Fundación Santiago Dexeus Font · Infertility
Phase 4
Completed
110
2026-04
Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
Instituto Bernabeu · IVF
Phase 4
Completed
150
2026-03
IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
Hanoi Medical University · Infertility (IVF Patients) · Embryo Morphokinetics
Not applicable
Recruiting
148
2026-02
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
University Hospital, Ghent · Ovarian Stimulation · Quality of Life
Phase 4
Recruiting
60
2025-12
DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT
Tam Anh TP. Ho Chi Minh General Hospital · Diminished Ovarian Reserve
Not applicable
Recruiting
730
2025-12
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.