Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 28, 2007

Last Updated Date

December 4, 2008

Start Date ^†

January 1999

Current Primary Outcome Measures ^†

testosterone [ Time Frame: daily for 7 days ] [ Designated as safety issue: No ]
LH [ Time Frame: frequent sampling for 2 hours ] [ Designated as safety issue: No ]
FSH [ Time Frame: frequent sampling for 2 hours ] [ Designated as safety issue: No ]
Inhibin B [ Time Frame: daily for 7 days ] [ Designated as safety issue: No ]
free alpha subunit [ Time Frame: daily for 7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00493961 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism

Official Title ^†

The Effects of 7 Days of Exogenous Pulsatile GnRH Treatment on the Pituitary-Gonadal Axis in Hypogonadotropic Hypogonadal Subjects

Brief Summary

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.

Detailed Description

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Condition ^†

Kallmann Syndrome
Idiopathic Hypogonadotropic Hypogonadism

Intervention ^†

Drug: gonadotropin releasing hormone (GnRH)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Diagnosis of idiopathic hypogonadotropic hypogonadism (IHH) or Kallmann syndrome (KS)Adult male 18-65 years of age
Serum testosterone <100 ng/dL

Exclusion Criteria:

No specific exclusion criteria

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Andrew Dwyer, RN, NP

617-726-8622

Adwyer@partners.org

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00493961

Responsible Party

William F. Crowley Jr., MD, MGH

Secondary IDs ^††

Study Sponsor ^†

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^††

Investigators ^†

Principal Investigator:

William F Crowley, Jr., MD

Massachusetts General Hospital / Harvard Medical School

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.