Hypogonadism Clinical Trial
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.
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.
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Primary Purpose: Screening
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 4 | |
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Phase 3 | |
| Withdrawn |
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|
N/A | |
| Completed |
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|
Phase 1 | |
| Completed |
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Oral Testosterone for the Treatment of Hypogonadism in Males
|
Phase 2 | |
| Completed |
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Phase 1/Phase 2 | |
| Terminated |
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NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
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Phase 4 | |
| Completed |
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|
N/A | |
| Completed |
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Phase 4 | |
| Completed |
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|
N/A | |
| Completed |
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|
N/A | |
| Completed |
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|
N/A | |
| Completed |
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Leuprolide in Treating Adults With Hypogonadotropism
|
N/A | |
| Withdrawn |
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Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
|
Phase 2 | |
| Completed |
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The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
|
Phase 2 | |
| Completed |
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Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™
|
Phase 4 | |
| Completed |
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|
Phase 2 | |
| Terminated |
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|
Phase 2 | |
| Completed |
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|
Phase 1 | |
| Terminated |
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|
N/A |