Skip to content

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00431197
Enrollment
40
Registered
2007-02-05
Start date
2004-02-29
Completion date
2007-12-31
Last updated
2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

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.

Interventions

DRUGKetoconazole, Dexamethesone, Androgel,GnRH

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
LH and Testosterone levels will be evaluated after 4 study visits

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026