Gonadotropin-releasing hormone agonists (GnRHa) are the standard of care for treating patients with central precocious puberty (CPP). However, there is a paucity of long-term, posttreatment follow-up data for patients previously treated with GnRHa.
The aim of this study was to provide long-term data documenting the reactivation of the hypothalamic–pituitary–ovarian (HPO) axis in girls with CPP who have been treated with histrelin subcutaneous implants (Supprelin LA).
This is an ongoing multicenter, observational patient registry. Girls diagnosed with CPP by 8 years of age, who started histrelin implant therapy by 8.5 years of age, and who are either currently on or have completed histrelin implant therapy are eligible. For this registry, CPP diagnostic criteria include breasts at Tanner stage 2 or higher and at least one of the following: random luteinizing hormone (LH) ≥0.3 IU/L and estradiol ≥20 pg/mL; GnRHa-stimulated LH ≥4 IU/L; or GnRHa-stimulated estradiol ≥20 pg/mL. Patients are treated by the investigators according to locally accepted clinical practices. Height and data related to puberty including Tanner stages, menarche or resumption of menses, puberty hormone levels (including LH, follicle-stimulating hormone, and estradiol), and bone age are extracted from charts or recorded during routine visits. Predicted adult height is calculated using the Bailey–Pinneau method. Primary end point is time to menarche or resumption of menses after discontinuing histrelin therapy. Patients will be followed for up to 3 years from the time of last implant removal.
Up to 150 girls are expected to be included in the registry. To date, 17 sites are participating, and 2 patients (age 7 and 9 years) have been enrolled. At baseline, both patients had a normal body mass index, and a Tanner staging breast score of 3. On-therapy data from the first set of patients in the registry will be presented. Any adverse drug reactions will also be discussed.
This is the first patient registry to assess the recovery of the HPO axis after discontinuing histrelin for the treatment of girls with CPP.
Data from this ongoing registry will help determine the effect of long-term continuous gonadotropin suppression in girls with CPP in regard to the timing of HPO axis recovery.
© 2012 Published by Elsevier Inc.