NCT01088399

A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults

The Global Hypopituitary Control and Complications Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,673 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypopituitarism
• Pituitary Insufficiency
• Growth Hormone Deficiency, Adult

Interventions

Type	Name	Description
DRUG	Somatropin (rDNA origin)	Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.

Timeline

• Start date: 2002-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-03-17
• Last updated: 2014-04-21
• Results posted: 2014-04-21