Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

AbbVie

Status and phase

Completed

Phase 3

Conditions

Gonadotrophin-releasing Hormone (GnRH)

Suppression of LH

Gonadotrophin-releasing Hormone Agonist (GnRHa)

Luteinizing Hormone (LH)

Precocious

Lupron

Pediatrics Central Precocious Puberty

Central Precocious Puberty (CPP)

Leuprolide Acetate

GnRH Analog

Tanner Staging

Depot Formulation

Treatments

Drug: Leuprolide Acetate 3 Month Depot

Study type

Interventional

Funder types

Industry

Identifiers

NCT00667446

L-CP07-177

Details and patient eligibility

About

The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).

Full description

This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Enrollment

72 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.

Exclusion criteria

Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
Current therapy with medroxyprogesterone acetate.
Current therapy with growth hormone.
Current therapy with insulin-like growth factor-1 (IGF-1).
Current use of an estrogen preparation.
Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
Subject has a positive pregnancy test.