NCT00004275

Brief Summary

RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

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

October 1, 1999

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

September 10, 2008

Status Verified

September 1, 2008

Enrollment Period

7.8 years

First QC Date

October 18, 1999

Last Update Submit

September 8, 2008

Conditions

Turner's Syndrome

Keywords

Turner's syndromegenetic diseases and dysmorphic syndromesrare disease

Interventions

growth hormoneDRUG
oxandroloneDRUG

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
PROTOCOL ENTRY CRITERIA: Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior estrogen, androgen, or growth hormone

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jefferson Medical College of Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-5083, United States

Location

MeSH Terms

Conditions

Turner SyndromeGenetic Diseases, InbornRare Diseases

Interventions

Growth HormoneOxandrolone

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 DisordersGonadal DisordersEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Judith L Ross

    Jefferson Medical College of Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

October 1, 1999

Primary Completion

August 1, 2007

Last Updated

September 10, 2008

Record last verified: 2008-09

Locations

US(1)