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

Sponsors and Collaborators:	Mayo Clinic 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 I

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Ketoconazole Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men

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:	January 2004

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	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Joy N. Bailey 507-255-0904 bailey.joy@mayo.edu
Principal Investigator: Johannes D. Veldhuis, M.D.

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Johannes D. Veldhuis, M.D.

Mayo Clinic

More Information

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

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

Study placed in the following topic categories:

Testosterone
Hypogonadism
Clotrimazole
Gonadal Disorders
Miconazole
Tioconazole

Endocrine System Diseases
Methyltestosterone
Endocrinopathy
Ketoconazole
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 14, 2009