drugset / Trial / NCT00136032

Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women

NCT00136032

Completed 63 enrolled Massachusetts General Hospital
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy: * has effects on women's cardiovascular risk markers (special blood tests which indicate how healthy the heart and arteries are) * has effects on women's types and levels of various substances circulating in their blood * in women affects the stiffness of their arteries and heart rate variability in parallel with changes in cardiovascular risk markers * has different effects depending on whether women are pre or post menopausal. Participation in this study is expected to last approximately 12 months.

Timeline

Start
2002-01
Primary completion
2006-11
Completion
2006-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Somatropin Protein / enzyme biologic 3 ug/kg
Comparator Somatropin Protein / enzyme biologic 6 ug/kg

Indications