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

NCT01710696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-02-28

No results posted yet for this study

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.

Conditions

  • Genetic Disorder
  • Turner Syndrome

Interventions

DRUG

17-beta estradiol

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

DRUG

17-beta estradiol

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-07-23
Primary Completion
2004-07-26
Completion
2004-07-26

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710696 on ClinicalTrials.gov