At a glance
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Feedback Control of FSH Secretion in the Human Male
In Brief
A clinical study evaluating ketoconazole and gonadotropin releasing hormone (GnRH) for Kallmann Syndrome and 2 related conditions. Completed, enrolled 175 participants across 1 site.
Detailed Summary
The purpose of the research study is to learn more about the regulation of reproductive hormones in adult men. We would like to understand what role testosterone and estradiol play in controlling the release of LH (lutenizing hormone) and FSH (follicle stimulating hormone). Testosterone and estradiol come from the testes, and LH and FSH are released from a gland in the head called the pituitary. Men involved in the study will have detailed evaluations that involve overnight stays in the hospital and frequent blood sampling. The men in the study will also be receiving medications that affect the levels of various hormones in the body. This will allow the researchers to learn how various hormones influence each other. Men that participate in the study will receive medical evaluations and monetary compensation. Information gathered from this study will help in the development of new treatments for infertility and potentially new hormonal forms of contraception.
Study Details
Timeline
Interventions
loading dose of 1g followed by a maintenance dose of 400 mg PO QID for 7 days
Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)