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

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ClinicalTrials.gov Identifier: NCT01710696
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Genetic Disorder Turner Syndrome Drug: 17-beta estradiol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial
Actual Study Start Date : July 23, 1998
Actual Primary Completion Date : July 26, 2004
Actual Study Completion Date : July 26, 2004


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

Experimental: Fixed dose Drug: 17-beta estradiol
0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally




Primary Outcome Measures :
  1. Pubertal stage assesed by Tanner score
  2. FSH (Follicle Stimulating Hormone) levels

Secondary Outcome Measures :
  1. Height velocity
  2. Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
  3. Adverse events


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710696


Locations
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Spain
Novo Nordisk Investigational Site
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, 28007
Novo Nordisk Investigational Site
Madrid, Spain, 28009
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Novo Nordisk Investigational Site
Madrid, Spain, 28041
Novo Nordisk Investigational Site
Madrid, Spain, 28046
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01710696     History of Changes
Other Study ID Numbers: GHTUR/E/2
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Genetic Diseases, Inborn
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs