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

Novo Nordisk A/S50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Genetic Disorder Turner Syndrome

Interventions

17-beta estradiolDRUG

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

17-beta estradiolDRUG

0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (28)

Novo Nordisk Investigational Site

Outcomes

Primary Outcomes

Pubertal stage assesed by Tanner score

FSH (Follicle Stimulating Hormone) levels

Secondary Outcomes

Height velocity

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

Adverse events

Data from ClinicalTrials.gov

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