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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01710696
Other study ID # GHTUR/E/2
Secondary ID
Status Completed
Phase Phase 3
First received October 16, 2012
Last updated February 27, 2017
Start date July 23, 1998
Est. completion date July 26, 2004

Study information

Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 26, 2004
Est. primary completion date July 26, 2004
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Spain Novo Nordisk Investigational Site Alicante
Spain Novo Nordisk Investigational Site Badajoz
Spain Novo Nordisk Investigational Site Baracaldo
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 La Laguna
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 Santa Cruz de Tenerife
Spain Novo Nordisk Investigational Site Santander
Spain Novo Nordisk Investigational Site Santiago de Compostela
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Tarrasa
Spain Novo Nordisk Investigational Site Valencia
Spain Novo Nordisk Investigational Site Valladolid
Spain Novo Nordisk Investigational Site Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pubertal stage assesed by Tanner score
Primary FSH (Follicle Stimulating Hormone) levels
Secondary Height velocity
Secondary Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
Secondary Adverse events
See also
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