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Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00431197
First received: February 2, 2007
Last updated: January 26, 2010
Last verified: January 2010
  Purpose
This study is being done to learn how the male hormone , testosterone, affects pituitary hormones in younger and older men. The pituitary is a gland in the brain that secretes hormones, some of which normally control growth and fertility.

Condition Intervention Phase
Hypogonadism
Drug: Ketoconazole, Dexamethesone, Androgel,GnRH
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • LH and Testosterone levels will be evaluated after 4 study visits

Estimated Enrollment: 40
Study Start Date: February 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:
Concentrations of bioavailable testosterone decline by 1.0-1.5% annually as men age. Reduced systemic testosterone availability is associated with decreased muscle mass, strength and aerobic capacity, decreased bone-mineral density and increased risk of hip fracture, waning sexual interest, inpaired spatial cognition and increased risk of visceral obesity, impaired glucose tolerance and coronary artery disease. Luteinizing hormone (LH) secretion often fails in healthy older individuals. In addition, aging is marked by an acceleration of LH pulse frequency, loss of high-amplitude LH pulses and disorderly release of LH and testosterone, as measured by the approximate entropy statistic. The mechanisms that underlie such complex adaptations are not known, but appear to involve multiple loci of regulatory failure.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • Healthy Men Ages 18-80
  • All ethnicities eligible
  • Men with indeterminate erectile dysfunction eligible with normal serum gonadotropin, total testosterone, prolactin and TSH concentrations and documented integrity of the neurovascular, cardiovascular, hepatorenal systems
  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: NCT00431197

Locations
United States, Minnesota
Mayo Clinic and Foundation
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Investigators
Principal Investigator: Johannes D. Veldhuis, M.D. Mayo Clinic
  More Information

ClinicalTrials.gov Identifier: NCT00431197     History of Changes
Other Study ID Numbers: 344-03  Minn # 22270 
Study First Received: February 2, 2007
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Hormones
Testosterone
Methyltestosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Ketoconazole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
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

ClinicalTrials.gov processed this record on December 08, 2016