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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual dose | Experimental |
| |
| Fixed dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-beta estradiol | Drug | 5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pubertal stage assesed by Tanner score | ||
| FSH (Follicle Stimulating Hormone) levels |
| Measure | Description | Time Frame |
|---|---|---|
| Height velocity | ||
| Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair | ||
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Alicante | 03010 | Spain | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 17-beta estradiol | Drug | 0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally |
|
| Badajoz |
| 06080 |
| Spain |
| Novo Nordisk Investigational Site | Barakaldo | 48903 | Spain |
| Novo Nordisk Investigational Site | Cáceres | 10002 | Spain |
| Novo Nordisk Investigational Site | Córdoba | 14004 | Spain |
| Novo Nordisk Investigational Site | El Palmar | 30120 | Spain |
| Novo Nordisk Investigational Site | Elche | 3203 | Spain |
| Novo Nordisk Investigational Site | Esplugues Llobregat | 08950 | Spain |
| Novo Nordisk Investigational Site | Granada | 18012 | Spain |
| Novo Nordisk Investigational Site | Jaén | 23007 | Spain |
| Novo Nordisk Investigational Site | Las Palmas | 35016 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28007 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28009 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28034 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28040 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28041 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29011 | Spain |
| Novo Nordisk Investigational Site | Salamanca | 37007 | Spain |
| Novo Nordisk Investigational Site | San Cristóbal de La Laguna | 38320 | Spain |
| Novo Nordisk Investigational Site | Santa Cruz de Tenerife | 38010 | Spain |
| Novo Nordisk Investigational Site | Santander | 39008 | Spain |
| Novo Nordisk Investigational Site | Santiago de Compostela | 15705 | Spain |
| Novo Nordisk Investigational Site | Seville | 41013 | Spain |
| Novo Nordisk Investigational Site | Tarrasa | 08227 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| Novo Nordisk Investigational Site | Valladolid | 47011 | Spain |
| Novo Nordisk Investigational Site | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D014424 | Turner Syndrome |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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