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

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) University of Michigan
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004335

Purpose

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.

Condition
Hypogonadism Precocious Puberty

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

Further study details as provided by National Center for Research Resources (NCRR):

Study Start Date:

April 1993

Detailed 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.

Eligibility

Ages Eligible for Study:	7 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004335

Locations

United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Michigan

Investigators

Study Chair:

Carol M. Foster

University of Michigan

More Information

No publications provided

Study ID Numbers:	199/11894, UMMC-271
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004335 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

endocrine disorders
growth hormone deficiency
hypogonadism
precocious puberty
rare disease

Study placed in the following topic categories:

Hypogonadism
Hypopituitary Dwarfism
Growth Hormone Deficiency
Gonadal Disorders
Puberty, Precocious
Rare Diseases

Precocious Puberty
Endocrine System Diseases
Endocrinopathy
Dwarfism, Pituitary
Hormones

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Puberty, Precocious
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 07, 2009