Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
---|---|
Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00493961 |
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.
Condition | Intervention |
---|---|
Kallmann Syndrome Idiopathic Hypogonadotropic Hypogonadism |
Drug: gonadotropin releasing hormone (GnRH) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | The Effects of 7 Days of Exogenous Pulsatile GnRH Treatment on the Pituitary-Gonadal Axis in Hypogonadotropic Hypogonadal Subjects |
Estimated Enrollment: | 50 |
Study Start Date: | January 1999 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew Dwyer, RN, NP | 617-726-8622 | Adwyer@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114-2696 | |
Contact: Andrew Dwyer, RN, NP 617-726-8622 Adwyer@partners.org | |
Sub-Investigator: Paul A Boepple, MD | |
Sub-Investigator: Frances J Hayes, MD | |
Sub-Investigator: Nelly Pitteloud, MD | |
Sub-Investigator: Stephanie B Seminara, MD | |
Sub-Investigator: Andrew Dwyer, RN, NP | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Andrew Dwyer, RN, NP 617-726-8622 Adwyer@partners.org |
Principal Investigator: | William F Crowley, Jr., MD | Massachusetts General Hospital / Harvard Medical School |
Responsible Party: | MGH ( William F. Crowley Jr., MD ) |
Study ID Numbers: | U54HD028138-447 |
Study First Received: | June 28, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00493961 |
Health Authority: | United States: Food and Drug Administration |
Kallmann Syndrome Idiopathic Hypogonadotropic Hypogonadism Hypothalamus |
Gonadal Disorders Nervous System Malformations Endocrine System Diseases Kallmann Syndrome Septo-optic dysplasia Methyltestosterone Sex Differentiation Disorders Testosterone 17 beta-cypionate |
Testosterone Hypogonadism Urogenital Abnormalities Genetic Diseases, Inborn Endocrinopathy Congenital Abnormalities Septo-Optic Dysplasia |
Pathologic Processes Disease Syndrome Nervous System Diseases |