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

• Status: Completed
• Trial end date: 2004-07-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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