Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome
NCT ID: NCT01710696
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
1998-07-23
2004-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Individual dose
17-beta estradiol
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
Fixed dose
17-beta estradiol
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally
Interventions
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17-beta estradiol
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
17-beta estradiol
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Alicante, , Spain
Novo Nordisk Investigational Site
Badajoz, , Spain
Novo Nordisk Investigational Site
Barakaldo, , Spain
Novo Nordisk Investigational Site
Cáceres, , Spain
Novo Nordisk Investigational Site
Córdoba, , Spain
Novo Nordisk Investigational Site
El Palmar, , Spain
Novo Nordisk Investigational Site
Elche, , Spain
Novo Nordisk Investigational Site
Esplugues Llobregat, , Spain
Novo Nordisk Investigational Site
Granada, , Spain
Novo Nordisk Investigational Site
Jaén, , Spain
Novo Nordisk Investigational Site
Las Palmas, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Málaga, , Spain
Novo Nordisk Investigational Site
Salamanca, , Spain
Novo Nordisk Investigational Site
San Cristóbal de La Laguna, , Spain
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, , Spain
Novo Nordisk Investigational Site
Santander, , Spain
Novo Nordisk Investigational Site
Santiago de Compostela, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Novo Nordisk Investigational Site
Tarrasa, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Valladolid, , Spain
Novo Nordisk Investigational Site
Zaragoza, , Spain
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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GHTUR/E/2
Identifier Type: -
Identifier Source: org_study_id
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