Clinical Trials Directory

Trials / Completed

CompletedNCT00004335

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

Status
Completed
Phase
Study type
Observational
Enrollment
Sponsor
National Center for Research Resources (NCRR) · NIH
Sex
All
Age
7 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
1993-04-01
First posted
1999-10-19
Last updated
2005-06-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00004335. Inclusion in this directory is not an endorsement.