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

Phase 3

Completed

• Conditions: Turner Syndrome; Genetic Disorder
• Interventions: Drug: 17-beta estradiol

• Registration Number: NCT01710696
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-07-23
• Primary Completion: 2004-07-26
• Study Completion: 2004-07-26
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual dose	17-beta estradiol	-
Fixed dose	17-beta estradiol	-

Primary Outcome Measures

Name	Time	Method
Pubertal stage assesed by Tanner score
FSH (Follicle Stimulating Hormone) levels

Secondary Outcome Measures

Name	Time	Method
Height velocity
Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Zaragoza, Spain