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Investigating the Regulation of Reproductive Hormones in Adult Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00392457
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : February 16, 2015
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Condition or disease Intervention/treatment Phase
Kallmann Syndrome Hypogonadism Gonadal Disorder Drug: ketoconazole Drug: gonadotropin releasing hormone (GnRH) Not Applicable

Detailed Description:
In the United States 10-15% couples seek evaluation for infertility, of whom a male factor is identified in approximately 50% of cases. To date, however, most infertility research has focused on the female partner and in the majority of instances the etiology of male infertility remains poorly understood with inconsistent elevation in FSH levels. Given that spermatogenesis is highly dependent on FSH secretion, this project will focus on delineating the feedback control of FSH in the human male. Such studies, although difficult to perform in the human, are critical to understanding not only the pathophysiology of male infertility, but also to determining the feasibility of hormonal approaches to male contraception. In this protocol, studies of normal, GnRH-deficient and agonadal men employing reversible sex steroid ablation, physiologic sex steroid replacement and manipulation of the GnRH input to the pituitary will permit the non-steroidal, sex steroid, and GnRH-dependent components of FSH regulation to be selectively elucidated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feedback Control of FSH Secretion in the Human Male
Study Start Date : July 1995
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Intervention Details:
  • Drug: ketoconazole
    loading dose of 1g followed by a maintenance dose of 400 mg PO QID for 7 days
  • Drug: gonadotropin releasing hormone (GnRH)
    Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)

Primary Outcome Measures :
  1. serum hormone levels [ Time Frame: Baseline, Day 3, and Day 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men aged 18 to 50 years
  • In good health
  • On no medications

Exclusion Criteria:

Subjects will not be enrolled in this study if there is a history of:

  • Liver disease or if screening blood tests demonstrate abnormal liver function tests
  • Excessive alcohol consumption
  • Illicit drug use
  • Severe drug allergy
  • Use of any concomitant medications
  • Peptic ulcer disease or gastritis

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 identifier (NCT number): NCT00392457

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: William F Crowley, Jr., MD Massachusetts General Hospital
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: William F. Crowley Jr., MD, MGH Identifier: NCT00392457    
Other Study ID Numbers: R01 HD15788 - 234
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: April 2010
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Idiopathic Hypogonadotropic Hypogonadism
Kallmann Syndrome
Additional relevant MeSH terms:
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Kallmann Syndrome
Gonadal Disorders
Endocrine System Diseases
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors