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Clinical Trials/NCT00431197
NCT00431197CompletedPhase 1

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

Mayo Clinic1 site in 1 country40 target enrollmentStarted: February 1, 2004Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
LH and Testosterone levels will be evaluated after 4 study visits

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Single Group
Masking
Double

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

LH and Testosterone levels will be evaluated after 4 study visits

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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