A study of Lupron Depot Lupron Depot in treatment of central premature puberty

• Conditions: Central Precocious Puberty; MedDRA version: 17.1Level: LLTClassification code 10073186Term: Central precocious pubertySystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-004495-36-Outside-EU/EEA
• Lead Sponsor: Abbvie previously known as Abbott

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-28
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Clinical diagnosis of isosexual CPP with onset of Tanner scores of B2 (breast) or
P2 (pubic hair) earlier than age 8.0 years for girls or P2 (pubic hair) or G2
(genitalia) earlier than 9.0 years for boys.
2. Confirmation of diagnosis by a pubertal response to a GnRH stimulation test
(LH = 10 U/L at baseline).
3. Chronological age less than 9.0 years for girls or less than 10.0 years for boys at
entry into the study at the time of the first injection.
4. Bone age advanced at least one year beyond chronological age by Fels Method at
entry into the study.
5. This condition may have been idiopathic or secondary to another lesion. If
secondary, therapy of the primary condition had been undertaken and stabilized.
6. No evidence of abnormal pituitary, adrenal, thyroid, and gonadal function except
for premature secretion of gonadotropins.
7. In general good health with no uncontrolled, clinically significant disease that
would mask the objectives of this protocol.
8. All the prestudy procedures were completed.
9. Eligible for therapy for at least 1 year.
10. The parent/guardian voluntarily signed the informed consent after its content was
explained.
Are the trial subjects under 18? yes
Number of subjects for this age range: 55
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Irradiation to the central nervous system.
2. Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified