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Initiating Transdermal Estradiol Therapy in Turner's Syndrome

NCT00870220 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2014-03-11

No results posted yet for this study

Summary

This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH) therapy.

The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment, low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating feminization, height velocity, and bone mineral density without compromising growth potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone in effects on feminization, height velocity, and bone mineral density.

Conditions

  • Turner's Syndrome

Interventions

DRUG

Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch

GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • University of Michigan

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Oklahoma

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • Thomas Jefferson University

    collaborator OTHER

  • University of Chicago

    lead OTHER

Principal Investigators

  • Robert L. Rosenfield, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
138 Months
Max Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00870220 on ClinicalTrials.gov