MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

PHASE3CompletedINTERVENTIONAL

Enrollment

306

Participants

Timeline

Start Date

May 31, 1993

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions

Fetal Growth Retardation

Interventions

DRUG

somatropin

0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years

DRUG

somatropin

0.2 IU/kg/day 7 days per week given continuously for 3 years

Trial Locations (1)

Sanofi-Aventis, Paris