CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
testosterone cypionate 200mg/mldrug
Likely dose
testosterone cypionate 200mg/mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02408445
NCT02408445Phase 4Completed
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Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment

University of Colorado, Denver·interventional·Posted Apr 3, 2015·Updated Apr 15, 2020

In Brief

A Phase 4 clinical trial evaluating testosterone cypionate 200mg/ml for Klinefelter Syndrome. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKlinefelter Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 3, 2015
Enrollment StartMay 8, 2015
Primary CompletionJan 31, 2018
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.2 years ago

Interventions

testosterone cypionate 200mg/mldrug

Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.