Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00004335
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:
NCT00004335
Study Brief:
Protocol Section:
NCT00004335