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Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency

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ClinicalTrials.gov Identifier: NCT00001180
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Information provided by:

Study Description
Brief Summary:

Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids. Amino acids are proteins that when combined make up different substances, like hormones. The order of amino acids in CRH, has been determined, meaning that the hormone can now be synthetically reproduced in a laboratory setting.

When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol. This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any of the steps of this process and result in a variety of diseases (Cushing's Syndrome and adrenal insufficiency).

Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to help diagnose and treat conditions of the HPA axis. This study will test the relationship for single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The oCRH will be injected into the patients vein as a single injection or slowly through an IV line over 24 hours. The participants will have blood tests taken to measure hormone levels before, during, and after receiving the oCRH.

Condition or disease Intervention/treatment
Adrenal Gland Hyperfunction Adrenal Gland Hypofunction Cushing's Syndrome Healthy Drug: Ovine Corticotropin-Releasing Hormone (oCRH)

Detailed Description:
Corticotropin-releasing hormone (CRH) is a 41 amino acid hypothalamic peptide whose chemical structure has recently been determined after more than two decades of intensive research. This peptide stimulates secretion of ACTH by the corticotroph cells of the pituitary gland. As with the previously discovered hypothalamic hormones, CRH has important diagnostic and therapeutic applications. This study seeks to explore these clinical applications by determining the dose-response relationship for single doses of ovine CRH (oCRH) in normal volunteers and in patients with disorders of the hypothalamic-pituitary-adrenal axis. CRH is administered intravenously at doses up to 10 pg/kg, given as a bolus or up to 1 ug/kg/b as a continuous infusion lasting up to 24 hours. Plasma levels of ACTH, cortisol and CRH are measured before, during and after CRH administration.

Study Design

Study Type : Observational
Estimated Enrollment : 2250 participants
Official Title: Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency
Study Start Date : March 1982
Estimated Study Completion Date : June 2005

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


The normal volunteers are obtained through the NIH volunteer program or are NIH employees. Normal volunteers are in excellent health and are receiving no chronic medications.

We now routinely test patients with hypocortisolism or hypercortisolism in our clinic and ward.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001180

United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information

ClinicalTrials.gov Identifier: NCT00001180     History of Changes
Other Study ID Numbers: 820045
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: June 2005

Keywords provided by National Institutes of Health Clinical Center (CC):
Corticotropin Releasing Hormone
Cushing Syndrome
Psychiatric Hypercortisolism
Adrenal Insufficiency
Normal Volunteer

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Corticotropin-Releasing Hormone
Epinephryl borate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents