Effects of Sex Hormones on Circadian Rhythm in Men and Women

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001285
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: October 1999
  Purpose

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.


Condition
Bipolar Disorder
Circadian Rhythm
Depressive Disorder

Study Type: Observational
Official Title: Chronobiologic Effects of Gonadal Steroid Manipulations in Volunteer Subjects

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 73
Study Start Date: August 1991
Estimated Study Completion Date: June 2000
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001285

Locations
United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001285     History of Changes
Other Study ID Numbers: 910206, 91-M-0206
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Circadian Rhythms
Environmental Light
Estrogen
Melatonin
Progesterone
Rapid Cycling Bipolar Disorder
Sleep
Testosterone
Depression
Hypomania
Mania

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 20, 2014