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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William F. Crowley, Jr., M.D., National Institute of Child Health and Human Development
ClinicalTrials.gov Identifier:
NCT00493961
First received: June 28, 2007
Last updated: August 31, 2017
Last verified: August 2017
  Purpose
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 GnRH Deficiency Drug: gonadotropin releasing hormone (GnRH)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of 7 Days of Exogenous Pulsatile GnRH Treatment on the Pituitary-Gonadal Axis in Hypogonadotropic Hypogonadal Subjects

Resource links provided by NLM:


Further study details as provided by William F. Crowley, Jr., M.D., National Institute of Child Health and Human Development:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 1999
Estimated Study Completion Date: May 2021
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gonadotropin releasing hormone (GnRH)
    Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493961

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
William F. Crowley, Jr., M.D.
Investigators
Principal Investigator: William F Crowley, Jr., MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:

Responsible Party: William F. Crowley, Jr., M.D., Professor, National Institute of Child Health and Human Development
ClinicalTrials.gov Identifier: NCT00493961     History of Changes
Other Study ID Numbers: U54HD028138-447
U54HD028138 ( U.S. NIH Grant/Contract )
Study First Received: June 28, 2007
Last Updated: August 31, 2017

Keywords provided by William F. Crowley, Jr., M.D., National Institute of Child Health and Human Development:
Kallmann Syndrome
Idiopathic Hypogonadotropic Hypogonadism
GnRH deficiency

Additional relevant MeSH terms:
Kallmann Syndrome
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
46, XY Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017