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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001232
Other study ID # 880132
Secondary ID 88-M-0132
Status Completed
Phase N/A
First received November 3, 1999
Last updated March 3, 2008
Start date July 1988
Est. completion date June 2000

Study information

Verified date July 1999
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date June 2000
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Age 18-65.

Female.

Use of barrier methods of birth control.

Not pregnant.

Not taking ongoing medications.

No medical illnesses.

Study Design

N/A


Locations

Country Name City State
United States National Institute of Mental Health (NIMH) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

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