Conditions: Precocious Puberty
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Intervention descriptions: intervention 1: One intra muscular injection at day 1 and month 3.

Protocol document: