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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00431197
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 40
• Location: 1
• Duration (Months): 46
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: Ketoconazole, Dexamethesone, Androgel,GnRH	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Official Title: Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. LH and Testosterone levels will be evaluated after 4 study visits []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Mayo Clinic

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00431197
• Other Study ID Numbers: 344-03; Minn # 22270
• First Posted: Feb 5, 2007
• Last Update Posted: Jan 28, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Hypogonadism; Ketoconazole; Testosterone

Study Results

No Results Posted as of Jan 28, 2010