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Androgen

Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution for Klinefelter Syndrome (TESTO Trial)

Phase 4
Waitlist Available
Led By Shanlee M Davis, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male infants with 47,XXY karyotype identified prenatally who are 4-12 weeks old (31 to 90 days of age). 47,XXY must be from a diagnostic test such as Chorionic Villus Sampling (CVS), amniocentesis, or post-natal blood/tissue. Non-invasive prenatal screening results alone will not be accepted.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

TESTO Trial Summary

This trial will study the effects of testosterone treatment in infant males with Klinefelter syndrome. All infants will receive testosterone treatment during the study. The study will follow the infants for six months to assess motor skills, body composition, and hormone levels.

TESTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TESTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Fat Percentage
Change in C14:1 Long Chain Acylcarnitines (LCAC) through targeted metabolomics
Change in Composite Motor Score on Alberta Infant Motor Scale
Secondary outcome measures
Change in Adaptive Functioning
Change in Anti-Mullerian Hormone (AMH)
Change in Cognitive and Language Composite Scores on the Bayley III
+17 more

TESTO Trial Design

2Treatment groups
Experimental Treatment
Group I: Visit 1 Placebo, Visit 2 DrugExperimental Treatment2 Interventions
Subjects in this group will be randomized to receive Placebo Injectable Saline beginning at visit 1, and Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution every 4 weeks x 3 doses beginning at visit 2.
Group II: Visit 1 Drug, Visit 2 PlaceboExperimental Treatment2 Interventions
Subjects in this group will be randomized to receive Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution every 4 weeks x 3 doses, beginning at visit 1, and Placebo Injectable Saline beginning at visit 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution
2017
Completed Phase 4
~80
Placebo injectable saline
2017
Completed Phase 4
~80

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,748 Previous Clinical Trials
2,163,894 Total Patients Enrolled
5 Trials studying Klinefelter Syndrome
443 Patients Enrolled for Klinefelter Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,976 Previous Clinical Trials
2,680,677 Total Patients Enrolled
Shanlee M Davis, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
51 Total Patients Enrolled
2 Trials studying Klinefelter Syndrome
51 Patients Enrolled for Klinefelter Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY
2017. "TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03325647.
~10 spots leftby May 2025
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