The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders

• Sponsor: National Institute of Mental Health (NIMH) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00001232
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Duration (Months): 143
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The normal menstrual cycle is produced by a series of hormonal signals that starts with the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is located in the brain and is often referred to as the master gland. GnRH then acts on the pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones directly involved in menstruation, estrogen and progesterone.

The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder; Healthy; Mental Disorders; Mood Disorders

Detailed Description

This protocol is designed to accompany clinical protocol #81-M-0126, "The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavior Disorders", as well as the submitted protocol, "The Phenomenology and Biophysiology of Climacteric and Menopause-Related Mood and Behavioral Disorders." Its purpose will be to evaluate hypothalamic-pituitary-gonadal axis regulation as measured by pituitary gonadotropin, i.e., follicle stimulating hormone (FSH) and luteinizing hormone (LH), response to intravenous administration of gonadotropin releasing hormone (GnRH) in menstrual cycle-related mood disorders.

Study Design

• Study Type: Observational
• Official Title: Pituitary Gonadotropin Response to GnRH Stimulation in Menstrual, Climacteric and, Menopause-Related Mood and Behavioral Disorders
• Study Start Date: Jul 1, 1988
• Study Completion Date: Jun 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Age 18-65.

Female.

Use of barrier methods of birth control.

Not pregnant.

Not taking ongoing medications.

No medical illnesses.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Mental Health (NIMH)	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Fujimoto VY, Klein NA, Battaglia DE, Bremner WJ, Soules MR. The anterior pituitary response to a gonadotropin-releasing hormone challenge test in normal older reproductive-age women. Fertil Steril. 1996 Mar;65(3):539-44.
• Rubinow DR, Hoban MC, Grover GN, Galloway DS, Roy-Byrne P, Andersen R, Merriam GR. Changes in plasma hormones across the menstrual cycle in patients with menstrually related mood disorder and in control subjects. Am J Obstet Gynecol. 1988 Jan;158(1):5-11.
• Schmidt PJ, Gindoff PR, Baron DA, Rubinow DR. Basal and stimulated gonadotropin levels in the perimenopause. Am J Obstet Gynecol. 1996 Sep;175(3 Pt 1):643-50.

• ClinicalTrials.gov Identifier: NCT00001232
• Other Study ID Numbers: 880132; 88-M-0132
• First Posted: Dec 10, 2002
• Last Update Posted: Mar 4, 2008
• Last Verified: Jul 1, 1999

• Keywords provided by , ,: Depression; FSH; GnRH; LH; Menopause; Menstrual Cycle
• Additional relevant MeSH terms: Disease; Depressive Disorder; Mental Disorders; Mood Disorders

Study Results

No Results Posted as of Mar 4, 2008