Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Triptorelin Pamoate

Criteria

Inclusion Criteria in the screening phase:

• Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys.

• Weight ≥ 20 kg.

Inclusion Criteria in the treatment phase:

• Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys.

• Age at evaluation less than 9 years for girls and 10 years for boys.

• A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).

• Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) > 1 year.

• Testosterone level ≥ 0.5 ng/ml in boys.

Exclusion Criteria:

• Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.

• Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.

• Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).

• The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.