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

NCT ID: NCT00490191

Last Updated: 2007-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2001-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypopituitarism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Somatropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Irvine, California, United States

Site Status

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.

La Jolla, California, United States

Site Status

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.

Palo Alto, California, United States

Site Status

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New Haven, Connecticut, United States

Site Status

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Jacksonville, Florida, United States

Site Status

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Atlanta, Georgia, United States

Site Status

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Chicago, Illinois, United States

Site Status

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Indianapolis, Indiana, United States

Site Status

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South Bend, Indiana, United States

Site Status

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Scarsborough, Maine, United States

Site Status

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Boston, Massachusetts, United States

Site Status

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St Louis, Missouri, United States

Site Status

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Albuquerque, New Mexico, United States

Site Status

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New York, New York, United States

Site Status

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Cincinnati, Ohio, United States

Site Status

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Cleveland, Ohio, United States

Site Status

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Nashville, Tennessee, United States

Site Status

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Dallas, Texas, United States

Site Status

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Houston, Texas, United States

Site Status

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Richmond, Virginia, United States

Site Status

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Tacoma, Washington, United States

Site Status

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Paris, , France

Site Status

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Berlin, , Germany

Site Status

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Roma, , Italy

Site Status

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Rio Piedras, , Puerto Rico

Site Status

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Manchester, Lancashire, United Kingdom

Site Status

Countries

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United States France Germany Italy Puerto Rico United Kingdom

Other Identifiers

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B9R-EW-T002

Identifier Type: -

Identifier Source: secondary_id

2073

Identifier Type: -

Identifier Source: org_study_id