Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.

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

Details

• Lead Sponsor: Ipsen
• Treatments: Triptorelin Pamoate

Criteria

Inclusion Criteria:

• The child must have completed study 2-54-52014-143

• The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects

Exclusion Criteria:

• The patient has a known hypersensitivity to any of the test materials or related compounds

• The patient is unable or unwilling to comply fully with the protocol