CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10,673 enrolled
Drug / intervention
Somatropin (rDNA origin)drug
Likely dose
Not stated in 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/NCT01088399
NCT01088399N/ACompleted

The Global Hypopituitary Control and Complications Study

Eli Lilly and Company·observational·Posted Mar 17, 2010·Updated Apr 21, 2014

In Brief

An observational study evaluating Somatropin (rDNA origin) for Hypopituitarism and 2 related conditions. Completed, enrolled 10,673 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2010
Enrollment StartSep 1, 2002
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 16.3 years ago

Interventions

Somatropin (rDNA origin)drug

Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.