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: October 10, 2013
Last verified: October 2013

May 28, 2009
October 10, 2013
April 2008
April 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00909844 on ClinicalTrials.gov Archive Site
  • 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 ]
  • LH response to 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 RIA [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • FSH response to GnRH test [ Time Frame: M12, M24, M36 M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
  • BMI and BMI 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 ]
Not Provided
Not Provided
 
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Precocious Puberty
Drug: Triptorelin (I.N.N.)
Decapeptyl® SR 11.25mg
Experimental: Triptorelin
Intervention: Drug: Triptorelin (I.N.N.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
November 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00909844
2-54-52014-159, 2008-000565-39
No
Ipsen
Ipsen
Not Provided
Study Director: Brigitte Palestro, MD Ipsen
Ipsen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP