CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 177 enrolled
Drug / intervention
Testosterone +1 moredrug
Likely dose
Testosterone (Androgel) 1.25, 2.5, 5, or 10 grams topically each day, or placeboAI-extracted
Key inclusion· 1
  • ✓Healthy men aged 60 to 75 years
Key exclusion· 10
  • ✕History of significant cardiac, renal, pulmonary, hepatic, benign prostatic hyperplasia, or malignant disease
  • ✕Current alcohol or illicit drug abuse, or major psychiatric disorders
  • ✕Current diagnoses of hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
  • ✕Use of medications affecting bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates, calcitonin, fluoride, glucocorticoids, thyroxine, lithium, vitamin D >2000 IU/day, or anti-convulsants

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00114114
NCT00114114N/ACompleted
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Dose-Response of Gonadal Steroids and Bone Turnover in Older Men

Massachusetts General Hospital·interventional·Posted Jun 14, 2005·Updated Oct 8, 2019

In Brief

A clinical study evaluating Testosterone and Goserelin acetate for Healthy Volunteers. Completed, enrolled 177 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA), Solvay Pharmaceuticals, AstraZeneca, AbbVie

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2005
Enrollment StartSep 1, 2004
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 13.2 yearsPosted 21.1 years ago

Interventions

Testosteronedrug

Androgel placebo or 1.25, 2.5, 5. or 10\* gms topically each day

Goserelin acetatedrug

3.6 gms sc every 4 weeks