The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
Primary Purpose
Depressive Disorder, Healthy, Mental Disorders
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Depressive Disorder focused on measuring Depression, FSH, GnRH, LH, Menopause, Menstrual Cycle
Eligibility Criteria
Age 18-65. Female. Use of barrier methods of birth control. Not pregnant. Not taking ongoing medications. No medical illnesses.
Sites / Locations
- National Institute of Mental Health (NIMH)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001232
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00001232
Brief Title
The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
Official Title
Pituitary Gonadotropin Response to GnRH Stimulation in Menstrual, Climacteric and, Menopause-Related Mood and Behavioral Disorders
Study Type
Observational
2. Study Status
Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
July 1988 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Healthy, Mental Disorders, Mood Disorders
Keywords
Depression, FSH, GnRH, LH, Menopause, Menstrual Cycle
7. Study Design
Enrollment
140 (false)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Age 18-65.
Female.
Use of barrier methods of birth control.
Not pregnant.
Not taking ongoing medications.
No medical illnesses.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2962499
Citation
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. doi: 10.1016/0002-9378(88)90765-x.
Results Reference
background
PubMed Identifier
8828428
Citation
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. doi: 10.1053/ob.1996.v175.a74255.
Results Reference
background
PubMed Identifier
8774283
Citation
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.
Results Reference
background
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The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
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