Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome

NCT ID: NCT01710696

Last Updated: 2017-02-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-23

Study Completion Date

2004-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Genetic Disorder Turner Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Individual dose

Group Type EXPERIMENTAL

17-beta estradiol

Intervention Type DRUG

5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally

Fixed dose

Group Type EXPERIMENTAL

17-beta estradiol

Intervention Type DRUG

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

Intervention Type DRUG

17-beta estradiol

0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Novo Nordisk Investigational Site

Badajoz, , Spain

Site Status

Novo Nordisk Investigational Site

Barakaldo, , Spain

Site Status

Novo Nordisk Investigational Site

Cáceres, , Spain

Site Status

Novo Nordisk Investigational Site

Córdoba, , Spain

Site Status

Novo Nordisk Investigational Site

El Palmar, , Spain

Site Status

Novo Nordisk Investigational Site

Elche, , Spain

Site Status

Novo Nordisk Investigational Site

Esplugues Llobregat, , Spain

Site Status

Novo Nordisk Investigational Site

Granada, , Spain

Site Status

Novo Nordisk Investigational Site

Jaén, , Spain

Site Status

Novo Nordisk Investigational Site

Las Palmas, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Málaga, , Spain

Site Status

Novo Nordisk Investigational Site

Salamanca, , Spain

Site Status

Novo Nordisk Investigational Site

San Cristóbal de La Laguna, , Spain

Site Status

Novo Nordisk Investigational Site

Santa Cruz de Tenerife, , Spain

Site Status

Novo Nordisk Investigational Site

Santander, , Spain

Site Status

Novo Nordisk Investigational Site

Santiago de Compostela, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Tarrasa, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Valladolid, , Spain

Site Status

Novo Nordisk Investigational Site

Zaragoza, , Spain

Site Status

Countries

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Spain

Related Links

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http://novonordisk-trials.com

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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