Completed

Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome

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What is being tested

growth hormone

+ oxandrolone

Drug
Who is being recruted

Congenital Abnormalities+21

+ Urogenital Diseases

+ Cardiovascular Diseases

From 10 to 14 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: September 10, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant human growth hormone (GH) and oxandrolone versus GH and placebo. GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. Treatment continues for 3 years; estrogen is offered after year 2. A study duration of 8 years is anticipated.

NCT00004275
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: September 10, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 10 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesCardiovascular DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersGonadal DysgenesisHeart Defects, CongenitalHeart DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesDisorders of Sex DevelopmentPathological Conditions, Signs and SymptomsUrogenital AbnormalitiesCardiovascular AbnormalitiesDisease AttributesChromosome DisordersSex Chromosome DisordersFemale Urogenital DiseasesMale Urogenital DiseasesSex Chromosome Disorders of Sex DevelopmentTurner SyndromeGenetic Diseases, InbornRare Diseases

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Jefferson Medical College of Thomas Jefferson University

Philadelphia, United StatesOpen Jefferson Medical College of Thomas Jefferson University in Google Maps
CompletedOne Study Center