Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Ketoconazole, Dexamethesone, Androgel,GnRH (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Johannes D. Veldhuis, M.D., Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men
Study design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: LH and Testosterone levels will be evaluated after 4 study visits
Secondary outcome: Unknown
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Male.
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
Locations and Contacts
Mayo Clinic and Foundation, Rochester, Minnesota 55905, United States; Recruiting
Joy N. Bailey, Phone: 507-255-0904, Email: bailey.joy@mayo.edu
Johannes D. Veldhuis, M.D., Principal Investigator
Additional Information
Clinical Trials at Mayo Clinic
Starting date: January 2004
Last updated: February 26, 2007
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