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

Primary Purpose

Genetic Disorder, Turner Syndrome

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
17-beta estradiol
17-beta estradiol
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genetic Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Individual dose

Fixed dose

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2012
Last Updated
February 27, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01710696
Brief Title
Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome
Official Title
Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 23, 1998 (Actual)
Primary Completion Date
July 26, 2004 (Actual)
Study Completion Date
July 26, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disorder, Turner Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual dose
Arm Type
Experimental
Arm Title
Fixed dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
17-beta estradiol
Intervention Description
5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
Intervention Type
Drug
Intervention Name(s)
17-beta estradiol
Intervention Description
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally
Primary Outcome Measure Information:
Title
Pubertal stage assesed by Tanner score
Title
FSH (Follicle Stimulating Hormone) levels
Secondary Outcome Measure Information:
Title
Height velocity
Title
Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
Title
Adverse events

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Cáceres
ZIP/Postal Code
10002
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Elche
ZIP/Postal Code
3203
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Esplugues Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santa Cruz de Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Tarrasa
ZIP/Postal Code
08227
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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