Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

• Status: Completed
• Trial end date: 2005-12-28
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Subjects who completed GHLiquid-1518.

• If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded.

• Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.

Exclusion Criteria:

• Subject with a history of acromegaly.

• Subject with diabetes mellitus.

• Subject suffering from malignancy.

• Several medical conditions