TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY

PHASE4CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

November 6, 2017

Primary Completion Date

May 5, 2021

Study Completion Date

May 5, 2021

Conditions
Klinefelter Syndrome
Interventions
DRUG

Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution

Subjects in one arm will be randomized to receive testosterone cypionate 200 mg/ml intramuscularly every 4 weeks for a total of three doses after visit 1, and receive placebo injectable saline for the same duration starting at visit 2. Subjects in the other arm will be randomized to receive placebo injectable saline every 4 weeks for a total of 3 doses after visit 1, and testosterone cypionate 200 mg/ml intramuscularly for the same duration starting at visit 2.

DRUG

Placebo injectable saline

Subjects in one arm will be randomized to receive testosterone cypionate 200 mg/ml intramuscularly every 4 weeks for a total of three doses after visit 1, and receive placebo injectable saline for the same duration starting at visit 2. Subjects in the other arm will be randomized to receive placebo injectable saline every 4 weeks for a total of 3 doses after visit 1, and testosterone cypionate 200 mg/ml intramuscularly for the same duration starting at visit 2.

Trial Locations (1)

80045

Children's Hospital Colorado, Aurora

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Colorado, Denver

OTHER

NCT03325647 - TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY | Biotech Hunter | Biotech Hunter