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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Genetic Disorder; Turner Syndrome

Treatments: Drug: 17-beta estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710696

GHTUR/E/2

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Individual dose

Experimental group

Treatment:

Drug: 17-beta estradiol

Drug: 17-beta estradiol

Fixed dose

Experimental group

Treatment:

Drug: 17-beta estradiol

Drug: 17-beta estradiol