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. The informed consent form, assent form and any privacy statement (e.g., HIPAA) must be approved by a local or central Institutional Review Board (IRB) as required by Regional, State and local regulations. Prior to performing any trial-related procedures, each subject's parent must review, understand, and sign an informed consent form. When determined to be appropriate (as specified either by the IRB and/or State and local regulations), each subject must also sign the assent form after having had an opportunity to review the form and have its contents explained and questions answered. 2. Subject completed the Treatment Period of the lead-in study, L-CP07-167, and has documented LH suppression as evidenced by peak-stimulated LH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosis of 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 (unresponsive to treatment/expanding) except hamartoma. 2. Bone age = 14.00 years for girls and = 15.00 years for boys (based on the Month 6 lead-in study, L-CP07-167, radiographic results). 3. Subject has an abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the subject from entering the study or subject with the following laboratory abnormalities: Creatinine > 1.5 mg/dL, ALT and/or AST > 2.0 × ULN, or total bilirubin > 2.0 mg/dL with AST/ALT elevated above normal limits. 4. Chronic illness requiring treatment that may interfere with growth, i.e., chronic steroid use, renal failure, moderate to severe scoliosis. 5. Current therapy with medroxyprogesterone acetate. 6. Current therapy with growth hormone. 7. Current therapy with insulin-like growth factor-1 (IGF-1). 8. Current use of an estrogen preparation. 9. 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. 10. Subject has a positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: “The objective of this study was to assess the long-term safety of continued treatment with 11.25 mg and 30 mg 3M depot formulations of leuprolide acetate over 36 months of treatment in children with CPP. This included the maintenance of LH suppression and the effects on pubertal symptoms, sex steroid levels, and bone age.”;Secondary Objective: Maintenance of LH suppression and the effects on pubertal symptoms, sex steroid levels and bone age.;Primary end point(s): There are no primary or secondary efficacy endpoints in this safety extension study. The following maintenance of suppression endpoints will be summarized for all subjects in each treatment group (11.25 mg leuprolide acetate or 30 mg leuprolide acetate). Baseline refers to the last measurement prior to the first injection in the lead-in study, L-CP07-167. ? Suppression of LH as determined by peak stimulated LH < 4 mIU/mL measured at Day 1, Month 6, 12, 24 and 36. ? Suppression of basal sex steroids (E2 < 20 pg/mL in girls and T < 30 ng/dL in boys) measured at Day 1, Months 3, 6, 9, 12, 18, 24, 30 and 36. ? Peak stimulated LH concentrations at Day 1, Months 6, 12, 24 and 36. ? Suppression of the physical signs of puberty at Day 1, Months 3, 6, 9, 12, 18, 24, 30 and 36 (subjects entering Study L-CP07-167 with Pubertal staging 5 will be excluded from this analysis), defined as: ? Regression or no progression of breast development according to Pubertal staging (in girls). ? Regression or no progression in testicular volume and genital staging according to Pubertal staging (boys). ? Change from baseline in growth rate at Day 1, Months 6, 12, 18, 24, 30 and 36 within each of the subgroups of subjects naïve to GnRHa treatment at baseline and previously treated. ? The ratio of change from baseline in bone age/change from baseline in chronological age at Day 1, Months 12, 24 and 36 within each of the subgroups of subjects naïve to GnRHa treatment at baseline and previously treated.;Timepoint(s) of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • There are no secondary efficacy endpoints in this safety extension study, see endpoints listed above ;Timepoint(s) of evaluation of this end point: • There are no secondary efficacy endpoints in this safety extension study, see endpoints listed above | — |
Countries
Puerto Rico, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed