NCT00309855

Brief Summary

This study is being done to understand how testosterone, the major male sex hormone, controls the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone, which controls sugar; fat and protein use in the body and maintains muscle strength and bone calcium content. Both testosterone and GH decline in older men. The age-related fall in these hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle wasting and impaired sexual function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2005

Typical duration 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

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

March 31, 2006

Last Update Submit

July 27, 2012

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Growth Hormone concentration after injections

    GH will be measured 4 different times mornings within 16-21 days following the first testosterone injection (day 1).

    24 days

Study Arms (4)

Double Placebo

PLACEBO COMPARATOR

(i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days)

Drug: Placebo

Testosterone IM and oral placebo

OTHER

IM injections weekly x three injections and oral placebo once daily x 21 days

Drug: Testosterone

Testosterone and Oral Anastrozole

OTHER

IM injections weekly x 3 injections and oral daily x 21 days

Drug: TestosteroneDrug: Anastrazole

Testosterone and Dutasteride

OTHER

IM injections weekly x 3 injections and oral once daily x 21 days

Drug: TestosteroneDrug: Dutasteride

Interventions

PlaceboDRUG

im and orally

Double Placebo
TestosteroneDRUG

injections

Testosterone IM and oral placeboTestosterone and DutasterideTestosterone and Oral Anastrozole
AnastrazoleDRUG

orally x 21 days

Testosterone and Oral Anastrozole
DutasterideDRUG

orally x 21 days

Testosterone and Dutasteride

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men between the ages of 50 and 80;
  • normal weight (within 30% of ideal body weight defined by New York Metropolitan Life tables); and
  • normal hematocrit (greater than 38%);
  • community dwelling; and
  • voluntarily consenting

You may not qualify if:

  • recent use of psychotropic or neuroactive drugs (within five biological half-live);
  • obesity (outside weight range above);
  • anemia (hematocrit \< 38%);
  • drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
  • acute or chronic organ-system disease;
  • endocrinopathy, other than primary thyroidal failure receiving replacement;
  • nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
  • acute weight change (loss or gain of \> 2 kg in 6 weeks);
  • allergy to administered compounds; and
  • unwillingness to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

TestosteroneAnastrozoleDutasteride

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzasteroidsSteroids, Heterocyclic

Study Officials

  • Johannes D. Veldhuis, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 3, 2006

Study Start

December 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

US(1)