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

Primary Purpose

Hypogonadism, Precocious Puberty

Status

Completed

Phase

Locations

United States

Study Type

Observational

Intervention

About this trial

This is an observational trial for Hypogonadism focused on measuring endocrine disorders, growth hormone deficiency, hypogonadism, precocious puberty, rare disease

Eligibility Criteria

7 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Michigan Health Systems

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004335

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00004335

Brief Title

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

Study Type

Observational

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Completed

Study Start Date

April 1993 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism, Precocious Puberty

Keywords

endocrine disorders, growth hormone deficiency, hypogonadism, precocious puberty, rare disease

7. Study Design

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol M. Foster

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Michigan Health Systems

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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