An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Children with growth failure due to inadequate secretion of growth hormone or growth
 retardation due to Turner's syndrome are individually dosed and treated for 12 weeks
Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation
 provides a higher concentration and thereby a smaller volume to be administered. ZomaJet
 Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin
 and into the subcutaneous tissue without the use of a needle. The mode of administration is
 referred to as "transjection". By use of ZomaJet Vision X, both transjection and
 reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the
 study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet
 Vision X.
Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to
 inadequate secretion of growth hormone or growth retardation due to Turner's syndrome.
 Subjects have for a minimum of 6 months prior to study enrolment been receiving growth
 hormone therapy