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OpenTrials
Completed

NCT Number: NCT01710696

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

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17-beta estradiol

Drug

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

Primary outcomes

  1. Pubertal stage assesed by Tanner score

  2. FSH (Follicle Stimulating Hormone) levels

Secondary outcomes

  1. Height velocity

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

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Oct 19, 2012
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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