Study of Lupron Depot in the Treatment of Central Precocious Puberty

Abbvie previously known as Abbott0 个研究点目标入组 55 人开始时间: 2014年11月28日最近更新: 2014年12月1日

试验速览

暂无简介。

•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
•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

•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).

发起方

Abbvie previously known as Abbott