Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle

Hypogonadism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004335
• Other study ID #: 199/11894
• Secondary ID: UMMC-271
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: April 1993

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH) and sex steroid secretion in normal and hypogonadal children.

II. Examine the acute effects of sex steroids on the sleep-entrained patterns of GnRH secretion in pubertal children and normal adults, either by stimulation of endogenous production with pulsatile injection or by intravenous infusion of GnRH.

III. Examine the role of endogenous opioids by means of opioid receptor blockade in the sex steroid regulation of GnRH secretion in pubertal children and normal adults.

Description:

PROTOCOL OUTLINE: This project involves several clinical protocols that study the regulation and role of pulsatile gonadotropin-releasing hormone (GnRH) secretion.

Studies include dynamic and repeated stimulation tests of pulsatile GnRH; plasma luteinizing hormone, follicular-stimulating hormone, testosterone (T), estradiol (E2), and GnRH measurements at cyclic and episodic intervals; and evaluation of adrenal androgen patterns.

Circadian rhythms of GnRH secretion are monitored during sleep and awake hours. Growth hormone secretory patterns and responses to provocative stimuli are studied as clinically indicated.

Selected participants undergo an assessment of pituitary responsiveness following T, E2, and/or naloxone infusions. The suppressive effects of E2 are also studied during the early follicular phase of the menstrual cycle.

Endocrinologically normal children and normal adult men and women are also studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 35 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Suspected or proven hypothalamic-pituitary-gonadal dysfunction, i.e.: Significant short stature and possible hypopituitarism Delayed adolescence Precocious puberty Isolated growth hormone deficiency (IGHD)Primary hypogonadism

• Women are also studied, including those with the following disorders: Infertility Oligo- or amenorrhea Hirsutism

--Patient Characteristics--

• Age: 7 to 16 (18 to 35 for women and volunteers)

• Other: No pregnant or nursing women No prisoners Not in neuropsychiatric institute or other facility for mental illness

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Hypogonadism
• Precocious Puberty
• Puberty, Precocious

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan

Country where clinical trial is conducted

United States,