Effects of Triptorelin Pamoate in Children With Precocious Puberty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Precocious Puberty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triptorelin

Group Type EXPERIMENTAL

Triptorelin (I.N.N.)

Intervention Type DRUG

Decapeptyl® SR 11.25mg

Interventions

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Triptorelin (I.N.N.)

Decapeptyl® SR 11.25mg

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No