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

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	July 1988
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
Official Title ^ICMJE	Pituitary Gonadotropin Response to GnRH Stimulation in Menstrual, Climacteric and, Menopause-Related Mood and Behavioral Disorders
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.
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 Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Depressive Disorder Healthy Mental Disorders Mood Disorders
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	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. 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	140
Completion Date	June 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	Age 18-65. Female. Use of barrier methods of birth control. Not pregnant. Not taking ongoing medications. No medical illnesses.
Gender	Female
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001232
Responsible Party
Study ID Numbers ^ICMJE	880132, 88-M-0132
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	July 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP