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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: May 28, 2009
Last updated: February 29, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Precocious Puberty
Drug: Triptorelin (I.N.N.)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Proportion of children with a stabilization or regression of Tanner pubertal stage at the end of the study, as compared to the stage at study entry (M6 of the phase III study 2-54-52014-143) [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Luteinizing Hormone (LH) response to Gonadotropin-Releasing Hormone (GnRH) tests [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • Levels of oestradiol in girls or testosterone in boys both measured by radioimmunoassay (RIA) [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • Follicle Stimulating Hormone (FSH) response to GnRH test [ Time Frame: M12, M24, M36 M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) and BMI Standard Deviation (SD) score for the chronological age variation [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • Auxological parameters variations (height, growth velocity, weight variation) [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • Bone age variation [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • Proportion of girls with an uterine length < 36 mm [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2008
Study Completion Date: January 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptorelin Drug: Triptorelin (I.N.N.)
Decapeptyl® SR 11.25mg


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00909844

Hôpital Hôtel Dieu (CHU)
Angers, France, 49033
Medical Centre
Bordeaux, France, 33000
Hôpital Flaubert
Le Havre, France, 76083
Hôpital Archet II
Nice, France, 06202
Hôpital Robert Debré
Paris, France, 75019
American Memorial Hospital
Reims, France, 51092
Hôpital Charles Nicolle
Rouen, France, 76031
Hôpital Hautepierre
Strasbourg, France, 67100
Hôpital de la Gespe
Tarbes, France, 65013
Hôpital des Enfants
Toulouse, France, 31026
Sponsors and Collaborators
Study Director: Olivier GATTOLLIAT, MD Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00909844     History of Changes
Other Study ID Numbers: 2-54-52014-159  2008-000565-39 
Study First Received: May 28, 2009
Last Updated: February 29, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Puberty, Precocious
Endocrine System Diseases
Gonadal Disorders
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 25, 2016