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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

April 1993

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief 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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening

Condition ^ICMJE

Hypogonadism
Precocious Puberty

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* 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

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 35 Years

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

NCT00004335

Responsible Party

Study ID Numbers ^ICMJE

199/11894, UMMC-271

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

Carol M. Foster

University of Michigan

Information Provided By

National Center for Research Resources (NCRR)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP