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OpenTrials
Completed

NCT Number: NCT00431197

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic and Foundation

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Ketoconazole, Dexamethesone, Androgel,GnRH

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 5, 2007
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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