NCT00140998

Brief Summary

The study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

November 30, 2017

Status Verified

August 1, 2017

First QC Date

August 30, 2005

Last Update Submit

November 28, 2017

Conditions

Turner SyndromeHypogonadismPremature Ovarian Failure

Keywords

Turner syndromeHypogonadismGHEstrogenEstrogen PatchesIGF-IBody CompositionProtein MetabolismLipolysis

Outcome Measures

Primary Outcomes (3)

  • Body Composition

  • Rates of whole body protein kinetics

  • Rates of whole body lipolysis

Secondary Outcomes (2)

  • Changes in IGF-I concentrations

  • Changes in Plasma Lipids

Interventions

17 beta estradiolDRUG

Eligibility Criteria

Age10 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Turner SyndromeHypogonadismPrimary Ovarian Insufficiency

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Nelly Mauras, MD

    Nemours Children's Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

January 1, 2001

Study Completion

June 1, 2004

Last Updated

November 30, 2017

Record last verified: 2017-08

Locations

US(1)