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

NCT01710696 | Completed Phase 3

• 1 other identifier: GHTUR/E/2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 28

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.

Conditions

Genetic Disorder; Turner Syndrome

Outcome Measures

Primary Outcomes (2)

• Pubertal stage assesed by Tanner score

• FSH (Follicle Stimulating Hormone) levels

Secondary Outcomes (3)

• Height velocity

• Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair

• Adverse events

Study Arms (2)

Individual dose

EXPERIMENTAL

Drug: 17-beta estradiol

Fixed dose

EXPERIMENTAL

Drug: 17-beta estradiol

Interventions

17-beta estradiol DRUG

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

Individual dose

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (28)

Novo Nordisk Investigational Site

Alicante, 03010, Spain

Location

Novo Nordisk Investigational Site

Badajoz, 06080, Spain

Location

Novo Nordisk Investigational Site

Barakaldo, 48903, Spain

Location

Novo Nordisk Investigational Site

Cáceres, 10002, Spain

Location

Novo Nordisk Investigational Site

Córdoba, 14004, Spain

Location

Novo Nordisk Investigational Site

El Palmar, 30120, Spain

Location

Novo Nordisk Investigational Site

Elche, 3203, Spain

Location

Novo Nordisk Investigational Site

Esplugues Llobregat, 08950, Spain

Location

Novo Nordisk Investigational Site

Granada, 18012, Spain

Location

Novo Nordisk Investigational Site

Jaén, 23007, Spain

Location

Novo Nordisk Investigational Site

Las Palmas, 35016, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28007, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28009, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28034, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28040, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28041, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28046, Spain

Location

Novo Nordisk Investigational Site

Málaga, 29011, Spain

Location

Novo Nordisk Investigational Site

Salamanca, 37007, Spain

Location

Novo Nordisk Investigational Site

San Cristóbal de La Laguna, 38320, Spain

Location

Novo Nordisk Investigational Site

Santa Cruz de Tenerife, 38010, Spain

Location

Novo Nordisk Investigational Site

Santander, 39008, Spain

Location

Novo Nordisk Investigational Site

Santiago de Compostela, 15705, Spain

Location

Novo Nordisk Investigational Site

Seville, 41013, Spain

Location

Novo Nordisk Investigational Site

Tarrasa, 08227, Spain

Location

Novo Nordisk Investigational Site

Valencia, 46026, Spain

Location

Novo Nordisk Investigational Site

Valladolid, 47011, Spain

Location

Novo Nordisk Investigational Site

Zaragoza, 50009, Spain

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Genetic Diseases, Inborn; Turner Syndrome

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 19, 2012
• Study Start: July 23, 1998
• Primary Completion: July 26, 2004
• Study Completion: July 26, 2004
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

ES (28)