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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Precocious Puberty

Treatments: Drug: Triptorelin (I.N.N.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909844

2-54-52014-159

2008-000565-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Triptorelin

Experimental group

Treatment:

Drug: Triptorelin (I.N.N.)