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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00909844
First received: May 28, 2009
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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
Estimated Study Completion Date: November 2015
Estimated 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
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
Ipsen
Investigators
Study Director: Brigitte Palestro, MD Ipsen
  More Information

No publications provided

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: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 01, 2014