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NCT01710696 Clinical Trial

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

Turner Syndrome Clinical Trial

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

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

Related Conditions & MeSH terms

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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Completed NCT01518036 - Use of Somatropin in Turner Syndrome Phase 3
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Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT00877942 - Sex Differences in Early Brain Development; Brain Development in Turner Syndrome N/A
Completed NCT00825617 - Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy N/A
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Terminated NCT00419107 - Beta Cell Function in Women With Turner Syndrome N/A
Active, not recruiting NCT00625001 - Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome N/A
Completed NCT00029159 - The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome Phase 3
Completed NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome Phase 4
Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
Completed NCT03181230 - Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

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