Genetic Disorder, Turner Syndrome
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.
Interventions
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Turner Syndrome * Treatment with growth hormone * Bone age minimum 12 years and maximum 14 years * Clear signs of ovarian insufficiency * Well documented growth rate during the last 12 months
Exclusion criteria
* Signs of spontaneous puberty * Known or suspected hypersensitivity to trial product * Acute or chronic liver disease * Previous treatment with estrogen * Undiagnosed abnormal genital bleeding * Known thyroid diseases not adeadequately treated * Porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pubertal stage assesed by Tanner score | — |
| FSH (Follicle Stimulating Hormone) levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Height velocity | — |
| Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair | — |
| Adverse events | — |
Countries
Spain
Outcome results
None listed