Central Precocious Puberty MedDRA version: 17.1 Level: LLT Classification code 10073186 Term: Central precocious puberty System Organ Class: 100000004860
Conditions
Sponsors
Abbvie previously known as Abbott
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the Phase 3 treatment period was to evaluate the safety and efficacy of leuprolide acetate for depot suspension in the treatment of CPP. Efficacy was evaluated based on Tanner staging and decrease of gonadotropins and sex steroids to prepubertal levels.;Secondary Objective: Not applicable;Primary end point(s): -Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) -Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) ;Timepoint(s) of evaluation of this end point: Time Frame: Weeks 4, 8, 12, 24, 36, 48, then every 6 months until end of treatment, and end of treatment day | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: •Hormone laboratory test results (LH suppression). Time Frame: Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until end of treatment, and end of treatment day. •Ratio of change in bone age to the change in chronological age. Time Frame: Weeks 24 and 48 then every 12 months until end of treatment and end of treatment day. •Predicted mature height. Time Frame: Weeks 24 and 48, then every 12 months until end of treatment, and end of treatment day.;Secondary end point(s): -Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations -Mean Stimulated Estradiol Concentrations in Females -Mean Stimulated Testosterone Concentrations in Males -Mean Ratio of Bone Age to Chronological Age | — |
Countries
United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbott Laboratories
Outcome results
None listed