Patient enrollment begun for central precocious puberty phase 3 implant study.

2004 OCT 7 - (NewsRx.com & NewsRx.net) -- Valera Pharmaceuticals it has initiated patient enrollment for a pivotal phase 3 trial of a 1-year implant for the hormonal treatment of central precocious puberty (CPP), an affliction characterized by the early onset of sexual development in preadolescents.

CPP, which is more prevalent in girls, results from an increased release by the pituitary gland of hormones called gonadotropins. The disorder causes physical changes that can begin in elementary school or sooner and which include breast development and ovulation in girls and sperm production in boys. Initially, CPP causes accelerated growth in stature, but eventually limits a child from attaining full adult height.

The Valera implant employs the company's patented Hydron drug delivery platform to provide the continuous 12-month administration of a controlled dose of histrelin, a synthetic nonapeptide agonist of the naturally occurring ...