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Safety and Efficacy of Long-term Somatropin Treatment in Adults (NordiWIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543880
First Posted: March 5, 2012
Last Update Posted: April 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).

Condition Intervention
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: Up to 10 years ]

Secondary Outcome Measures:
  • BMI (Body Mass Index) [ Time Frame: Up to 10 years ]
  • HbA1c change [ Time Frame: Up to 10 years ]
  • IGF-I (Insulin-Like Growth Factor I) [ Time Frame: Up to 10 years ]

Enrollment: 752
Study Start Date: July 2003
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Users of somatropin Drug: somatropin
Prescribed at the discretion of the treating physician according to product labelling

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults in need of somatropin or current users
Criteria

Inclusion Criteria:

  • In need of somatropin or current user
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543880


Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01543880     History of Changes
Other Study ID Numbers: GH-1931
First Submitted: February 28, 2012
First Posted: March 5, 2012
Last Update Posted: April 29, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases