Completed

The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome

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What is being tested

Humatrope

+ Oxandrolone

Drug
Who is being recruted

Congenital Abnormalities+21

+ Urogenital Diseases

+ Bone Diseases

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

Treatment Study

Phase 2
Interventional
Study Start: December 1992
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: December 11, 1992

Actual date on which the first participant was enrolled.

Turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables.

NCT00001343
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: July 2, 2017
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 DiseasesBone DiseasesBone Diseases, DevelopmentalCardiovascular DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersGonadal DysgenesisHeart Defects, CongenitalHeart DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisorders of Sex DevelopmentUrogenital AbnormalitiesCardiovascular AbnormalitiesChromosome DisordersSex Chromosome DisordersGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesSex Chromosome Disorders of Sex DevelopmentDwarfismTurner Syndrome

Criteria

INCLUSION CRITERIA: Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria: Karyotype diagnosis compatible with Turner syndrome. No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months. Chronological age of 10.0 to 14.9 years. Bone age less than or equal to 12 years. EXCLUSION CRITERIA: Prior treatment with estrogen, androgen, or growth hormone for more than twelve months. Y component in peripheral karyotype.

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 2 locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps

Thomas Jefferson University

Philadelphia, United States
Completed2 Study Centers