A Phase 1 interventional study of gonadotropin releasing hormone (GnRH) in Kallmann Syndrome, Idiopathic Hypogonadotropic Hypogonadism and GnRH Deficiency, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Massachusetts General Hospital · Phase 1, Interventional, and Other
Men with Idiopathic Hypogonadotropic Hypogonadism (IHH) lack a hormone called gonadotropin releasing hormone (GnRH). This hormone is important for starting puberty, maintaining testosterone levels, and fertility. The purpose of this study is to research the effects of treating IHH men with GnRH for 7 days.
Despite variability in the triggers, timing, and pace of sexual maturity between species, all species utilize the final pathway of hypothalamic secretion of gonadotropin releasing hormone (GnRH) to initiate and maintain the reproductive axis. Thus, GnRH is required for reproductive competence in the human. The classic studies from the 1970s clearly demonstrate that pulsatile release of GnRH from the hypothalamus is a prerequisite for physiologic gonadotrope function. Absence, decreased frequency or decreased amplitude of pulsatile GnRH release results in the clinical syndrome of hypogonadotropic hypogonadism (HH). The phenotypic expression of GnRH deficiency in the human demonstrates considerable heterogeneity. Defining the physiology of GnRH is critical to understanding the clinical heterogeneity of isolated GnRH deficiency and its comparison to other conditions resulting in hypogonadotropic hypogonadism (HH). The overall goal of this protocol is to investigate the neuroendocrine control of reproduction and specifically the physiology and pathophysiology of GnRH secretion and action in the human male.
Subjects will be selected from a group of adult men (18-65 years)based on the demonstration of a low testosterone level (\<100 ng/dL) in association with low or inappropriately normal gonadotropin levels. All patients will undergo an initial assessment that includes an overnight 12-hour frequent blood sampling study to determine their degree of endogenous GnRH secretion. Following the overnight evaluation, subjects will have daily outpatient visits for 7 consecutive days when they will receive a GnRH bolus followed by 2hrs of blood sampling.
21 studies on the registry are indexed under Kallmann Syndrome; 5 are open to participants now.
This study's enrollment of 27 is below the median of 100 across 13 interventional studies indexed under Kallmann Syndrome.
Browse Kallmann Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump)
testosterone
Time frame: daily for 7 days
LH
Time frame: frequent sampling for 2 hours
FSH
Time frame: frequent sampling for 2 hours
Inhibin B
Time frame: daily for 7 days
free alpha subunit
Time frame: daily for 7 days
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital