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Completed

NCT Number: NCT01543880

Safety and Efficacy of Long-term Somatropin Treatment in Adults

This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).

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Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In need of somatropin or current user

Treatment and study plan

Somatropin

Drug

Prescribed at the discretion of the treating physician according to product labelling

Primary outcomes

  1. Number of adverse events

    Time frame: Up to 10 years

Secondary outcomes

  1. BMI (Body Mass Index)

    Time frame: Up to 10 years

  2. HbA1c change

    Time frame: Up to 10 years

  3. IGF-I (Insulin-Like Growth Factor I)

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults

Acronym: NordiWIN

Important dates

Study start
2003
Primary completion
2013
Study completion
2014
First posted
Mar 5, 2012
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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