CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Somatropin +1 moredrug
Likely dose
Somatropin 6 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00136032
NCT00136032N/ACompleted

Gender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone Deficiency

Massachusetts General Hospital·interventional·Posted Aug 26, 2005·Updated Feb 18, 2008

In Brief

A clinical study evaluating Somatropin and Placebo for Growth Hormone Deficiency. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2005
Enrollment StartJan 1, 2002
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago

Interventions

Somatropindrug

Stratified based on age and estrogen status from 3 to 6 mcg/kg/day

Placebodrug

Dosage based on age and estrogen status ranging from 3 to 6 mcg/kg/day