Clinical trial NCT01710696: Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome
Official title: Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genetic Disorder
Turner Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-19
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pubertal stage assesed by Tanner score
measure: FSH (Follicle Stimulating Hormone) levels
Secondary outcomes:
measure: Height velocity
measure: Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
measure: Adverse events
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Novo Nordisk Investigational Site
city: Badajoz
country: Spain
facility: Novo Nordisk Investigational Site
city: Baracaldo
country: Spain
facility: Novo Nordisk Investigational Site
city: Cáceres
country: Spain
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Spain
facility: Novo Nordisk Investigational Site
city: El Palmar
country: Spain
facility: Novo Nordisk Investigational Site
city: Elche
country: Spain
facility: Novo Nordisk Investigational Site
city: Esplugues Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Jaén
country: Spain
facility: Novo Nordisk Investigational Site
city: La Laguna
country: Spain
facility: Novo Nordisk Investigational Site
city: Las Palmas
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Salamanca
country: Spain
facility: Novo Nordisk Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Santiago de Compostela
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Tarrasa
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Valladolid
country: Spain
facility: Novo Nordisk Investigational Site
city: Zaragoza
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: