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Home > "S" Clinical Trials Conditions > Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
For Condition: Hypogonadism,Precocious Puberty
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Child Health and Human Development (NICHD),University of Michigan
Synopsis: 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.
Details: 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:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 7 Years/35 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolFoster, Study Chair, University of Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
United States
Additional Information:
Study ID Numbers: 199/11894; UMMC-271
Study Start Date: April 1993
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004335
Other Hypogonadism Studies:
1. Prevention of Osteoporosis in Men with Prostate Cancer
2. Ovarian Follicle Function in Patients with Premature Ovarian Failure
3. Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism
4. Testosterone and Growth Hormone for Bone Loss in Men
5. Leuprolide in Treating Adults With Hypogonadotropism
Related Studies:
Other Hypogonadism Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
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