CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Testosterone gel 1% +1 moredrug
Likely dose
Not stated in 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/NCT01585831
NCT01585831N/ACompleted
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Psychological and Motor Effects of Testosterone Therapy in Adolescents With XXY/Klinefelter Syndrome

University of Colorado, Denver·interventional·Posted Apr 26, 2012·Updated Aug 10, 2021

In Brief

A clinical study evaluating Testosterone gel 1% and Placebo gel for Klinefelter Syndrome and XXY Syndrome. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if testosterone replacement therapy leads to changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also called Klinefelter syndrome). This study will also evaluate whether certain genetic factors of the X chromosome affect the psychological or motor features of XXY/Klinefelter syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKlinefelter Syndrome, XXY Syndrome
CountriesUnited States
CollaboratorsColorado Clinical & Translational Sciences Institute, Children's Hospital Colorado, National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2012
Enrollment StartMar 1, 2012
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 14.2 years ago

Interventions

Testosterone gel 1%drug

Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.

Placebo geldrug

The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.