A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label,
global, multicentre, observational study on routine clinical care of adults with growth
hormone deficiency occurring either isolated or in combination with other pituitary hormone
deficiencies. The objective of this observational study is to evaluate long-term safety and
health outcomes for adult growth hormone deficient participants with or without somatropin
replacement therapy. As an observational study, data are collected only as provided at the
discretion of the attending physician. The participant enrolled meet the criteria of growth
hormone deficiency in adults as per the Humatrope label in the country where their attending
physician practices, and this diagnosis is at the discretion of the attending physician. The
decision to receive somatropin or remain untreated is made by the participant in consultation
with their attending physician.
While treatment of adult growth hormone deficient participants with somatropin has been shown
to be safe and effective in clinical trials of 18 months duration, this observational study
aims to provide information on health outcome and replacement therapy over longer periods of
time for a larger number of participants in the context of the overall disease environment.