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Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients

NCT00570011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2007-12-11

No results posted yet for this study

Summary

An international study in which patients with GHD were randomized to receive somatropin at a dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

Somatropin

3 microg/kg/day for the first three months.The dose was then doubled (6 microg/kg/day) for the next three-months.

DRUG

Somatropin

6 microg/kg/day for the first three months. The dose was then doubled (12 microg/kg/day) for the next three-months.

Sponsors & Collaborators

  • University of Naples

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • Eli Lilly and Company

    lead INDUSTRY

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-06-30
Completion
1998-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570011 on ClinicalTrials.gov