MedTrace Logo

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

NCT01088399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10673

Last updated 2014-04-21

Study results available
· View outcomes & findings →

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

DRUG

Somatropin (rDNA origin)

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01088399 on ClinicalTrials.gov