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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431197
• Other study ID #: 344-03
• Secondary ID: Minn # 22270
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2007
• Last updated: January 26, 2010
• Start date: February 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Ketoconazole, Dexamethesone, Androgel,GnRH

Locations

Country	Name	City	State
United States	Mayo Clinic and Foundation	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LH and Testosterone levels will be evaluated after 4 study visits
Secondary	Unknown