Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

August 31, 2006

Study Completion Date

August 31, 2010

Conditions
Hypopituitarism
Interventions
DRUG

Arimidex (Anastrozole)

Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.

DRUG

Placebo

Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.

DRUG

Growth Hormone

GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of \~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.

Trial Locations (1)

32207

Nemours Children's Clinic, Jacksonville

Sponsors
All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

collaborator

EMD Serono

INDUSTRY

lead

Nemours Children's Clinic

OTHER