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OpenTrials
Completed

NCT Number: NCT00490191

Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency

This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

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Key information

Conditions

Hypopituitarism Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Paris, France

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About this study

Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total).

Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have growth hormone deficiency that started in childhood or adulthood
  • Have not received any growth hormone treatment in the last 12 months
  • Have had a growth hormone stimulation test within the last two years showing abnormally low response
  • Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months

Exclusion criteria

  • Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases
  • Recent growth of pituitary tumor or other intracranial tumor
  • History of acromegaly
  • Taking medication to suppress appetite or reduce weight, or antidepressant drugs
  • Poorly-controlled high blood pressure or diabetes

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Percent change in total fat mass

    Time frame: Eight months

Secondary outcomes

  1. Safety

    Time frame: Eight months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency

Important dates

Study start
1999
Study completion
2001
First posted
Jun 22, 2007
Registry last updated
Jun 22, 2007

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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