Study of Lupron Depot In The Treatment of Central Precocious Puberty

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

January 31, 1991

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Puberty, Precocious
Interventions
DRUG

Lupron (leuprolide acetate)

Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

Trial Locations (9)

17033

Site Reference ID/Investigator# 14344, Hershey

21201

Site Reference ID/Investigator# 46672, Baltimore

33701

Site Reference ID/Investigator# 14341, St. Petersburg

46202

Site Reference ID/Investigator# 14342, Indianapolis

80045

Site Reference ID/Investigator# 14343, Aurora

85006

Site Reference ID/Investigator# 46673, Phoenix

94122

Site Reference ID/Investigator# 46671, San Francisco

94305

Site Reference ID/Investigator# 14921, Stanford

01199

Site Reference ID/Investigator# 46668, Springfield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY