Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

PHASE4CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

November 30, 1989

Primary Completion Date

September 30, 2003

Study Completion Date

September 30, 2003

Conditions
Genetic DisorderTurner Syndrome
Interventions
DRUG

somatropin

4 IU/m\^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

DRUG

somatropin

Initial dose 4 IU/m\^2 body surface the first year, then 6 IU/m\^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

DRUG

somatropin

Initial dose 4 IU/m\^2 body surface the first year, then 6 IU/m\^2 body surface, the second year and finally 8 IU/m\^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

DRUG

oestrogen

Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment

Trial Locations (1)

Unknown

Novo Nordisk Investigational Site, Alphen aan den Rijn

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome | Biotech Hunter | Biotech Hunter