Effects of Sex Hormones on Circadian Rhythm in Men and Women

For many years researchers have been trying to better understand the regulation of sleep and activity by studying circadian (daily) rhythms of human beings. It appears that the hormones estrogen, progesterone, and testosterone play a role in the regulation of circadian rhythm in animals. Researchers believe these hormones may also play a similar role in the regulation of human circadian rhythms. Little research has been conducted on how these hormones affect human circadian rhythms.

This study is designed to learn more about how specific hormones influence men and women's daily rhythms. This study will use women from another research study being conducted at the NIMH called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone". Male subjects will be recruited from another NIMH study called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement".

In order to test the possibility that gonadal steroids (estrogen, progesterone, and testosterone) change circadian rhythms and the sleep-wake cycle in humans, participants will undergo chronobiologic evaluations. The chronobiologic evaluations will look at sleep and rest periods, activity as measured by a wrist monitor, and 24 hour inpatient electroencephalograph (EEG), rectal temperature, and melatonin monitoring.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Circadian Rhythm Depression Depressive Disorder Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Observational

Primary location

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

About this study

It is hypothesized that gonadal steroids modulate circadian rhythms and the sleep-wake cycle in humans, as they do in animals. This hypothesis will be tested by performing chronobiologic evaluations on women enrolled in protocol 92-M-0174 ("The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone") and on men enrolled in protocol 94-M-0037 (The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement"). Based on the animal literature, we hypothesize that melatonin and sleep onset will be phase-advanced in women on estrogen, compared with those on progesterone or in a hypogonadal state. We also hypothesize that the amplitude of the activity cycle will be decreased in the progesterone, as compared with the estrogen, condition. Based on findings in amenorrheic women and in those on oral contraceptives, we hypothesize that the amplitude of melatonin secretion will be increased in the hypogonadal state, compared with the other two conditions. Finally, based on literature cited below, we hypothesize that mean prolactin levels will be higher in the testosterone plus Lupron condition and in the estrogen plus Lupron condition than in the other hormonal conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Volunteers must be healthy individuals between the ages of 18 and 45 years old.

No pregnant women.

No history of menstrually-related mood or behavioral disturbances.

No volunteers with current or past Axis I diagnoses, significant abnormalities on physical or neurological examination, or significant laboratory abnormalities.

Must be HIV negative.

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health (NIMH)

Nih

Registry information

Official study title

Chronobiologic Effects of Gonadal Steroid Manipulations in Volunteer Subjects

Important dates

Study start: 1991
Study completion: 2000
First posted: Dec 10, 2002
Registry last updated: Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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