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

February 27, 2017 updated by: Novo Nordisk A/S

Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Novo Nordisk Investigational Site
      • Badajoz, Spain, 06080
        • Novo Nordisk Investigational Site
      • Baracaldo, Spain, 48903
        • Novo Nordisk Investigational Site
      • Cáceres, Spain, 10002
        • Novo Nordisk Investigational Site
      • Córdoba, Spain, 14004
        • Novo Nordisk Investigational Site
      • El Palmar, Spain, 30120
        • Novo Nordisk Investigational Site
      • Elche, Spain, 3203
        • Novo Nordisk Investigational Site
      • Esplugues Llobregat, Spain, 08950
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Jaén, Spain, 23007
        • Novo Nordisk Investigational Site
      • La Laguna, Spain, 38320
        • Novo Nordisk Investigational Site
      • Las Palmas, Spain, 35016
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28009
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28040
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28007
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28041
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29011
        • Novo Nordisk Investigational Site
      • Salamanca, Spain, 37007
        • Novo Nordisk Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39008
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15705
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
      • Tarrasa, Spain, 08227
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
      • Valladolid, Spain, 47011
        • Novo Nordisk Investigational Site
      • Zaragoza, Spain, 50009
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual dose
Drug: 17-beta estradiol
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
Drug: 17-beta estradiol
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally
Experimental: Fixed dose
Drug: 17-beta estradiol
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
Drug: 17-beta estradiol
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pubertal stage assesed by Tanner score
FSH (Follicle Stimulating Hormone) levels

Secondary Outcome Measures

Outcome Measure
Adverse events
Height velocity
Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 1998

Primary Completion (Actual)

July 26, 2004

Study Completion (Actual)

July 26, 2004

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHTUR/E/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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