NCT00431197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

3.8 years

First QC Date

February 2, 2007

Last Update Submit

January 26, 2010

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • LH and Testosterone levels will be evaluated after 4 study visits

Interventions

Ketoconazole, Dexamethesone, Androgel,GnRHDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic and Foundation

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johannes D. Veldhuis, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

February 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

US(1)