Long-Term Continuous Suppression With Once-Yearly Histrelin Subcutaneous Implants for the Treatment of Central Precocious Puberty: A Final Report of a Phase 3 Multicenter Trial.

ABSTRACT:

Context and objective

The histrelin implant has proven to be an effective method of delivering GnRH analog (GnRHa) therapy to children with central precocious puberty (CPP), yet there are limited data available regarding hormonal suppression and auxological changes during an extended course of therapy.

Design

This was a phase 3, prospective, open-label study.

Setting and participants

Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.

Outcome measures

Hormone levels and auxologic parameters were measured periodically for up to 6 years of treatment and up t

SUBMITTER: Silverman LA 

PROVIDER: S-EPMC4504932 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature