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

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ClinicalTrials.gov Identifier: NCT00493961
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Kallmann Syndrome Idiopathic Hypogonadotropic Hypogonadism GnRH Deficiency Drug: gonadotropin releasing hormone (GnRH) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of 7 Days of Exogenous Pulsatile GnRH Treatment on the Pituitary-Gonadal Axis in Hypogonadotropic Hypogonadal Subjects
Study Start Date : January 1999
Actual Primary Completion Date : November 17, 2009
Actual Study Completion Date : November 17, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones


Intervention Details:
  • Drug: gonadotropin releasing hormone (GnRH)
    Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump)


Primary Outcome Measures :
  1. testosterone [ Time Frame: daily for 7 days ]
  2. LH [ Time Frame: frequent sampling for 2 hours ]
  3. FSH [ Time Frame: frequent sampling for 2 hours ]
  4. Inhibin B [ Time Frame: daily for 7 days ]
  5. free alpha subunit [ Time Frame: daily for 7 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493961


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Seminara B Stephanie, MD Massachusetts General Hospital
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00493961    
Other Study ID Numbers: U54HD028138-447
U54HD028138 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022
Keywords provided by Stephanie B. Seminara, MD, Massachusetts General Hospital:
Kallmann Syndrome
Idiopathic Hypogonadotropic Hypogonadism
GnRH deficiency
Additional relevant MeSH terms:
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Kallmann Syndrome
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs