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

Sponsor:	Mayo Clinic
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00431197

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:

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Ketoconazole

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

LH and Testosterone levels will be evaluated after 4 study visits

Secondary Outcome Measures:

Unknown

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
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

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

Additional Information:

Clinical Trials at Mayo Clinic This link exits the ClinicalTrials.gov site

No publications provided

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
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Hormones
Ketoconazole
Androgens
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 24, 2012