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Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty (DECAPUB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564850
First Posted: November 28, 2007
Last Update Posted: February 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
November 27, 2007
November 28, 2007
November 1, 2011
December 1, 2011
February 13, 2012
October 2007
October 2010   (Final data collection date for primary outcome measure)
Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L [ Time Frame: 3 months after the first injection of triptorelin pamoate 11.25 mg ]
Proportion of children with a negative LH response to GnRH test: stimulated LH < 3 IU/l [ Time Frame: 3 months after the first injection of triptorelin pamoate 11.25 mg ]
Complete list of historical versions of study NCT00564850 on ClinicalTrials.gov Archive Site
  • Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L [ Time Frame: Month 6 ]
  • Follicle Stimulating Hormone (FSH) Level Following GnRH Test [ Time Frame: Screening, month 3 and 6 ]
  • Basal FSH Level [ Time Frame: Month 0, 1, 2, 3, 4, 5, and 6 ]
  • Basal LH Level [ Time Frame: Month 0, 1, 2, 3, 4, 5 and 6 ]
  • Number of Girls With Oestradiol Levels ≤ 20 pg/ml [ Time Frame: Month 0, 1, 2, 3, 4, 5 and 6 ]
  • Testosterone Level [ Time Frame: Month 0, 3 and 6 ]
  • Number of Girls With Inhibin B Levels < 6 pg/ml [ Time Frame: Month 0, 3 and 6 ]
  • Change From Screening in Pubertal Stage (Tanner Method) at Month 6 [ Time Frame: Between screening and month 6 ]
    Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.
  • Height Standard Deviation Score (SDS) [ Time Frame: Month 0, 3 and 6 ]
    Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.
  • Body Mass Index (BMI) SDS [ Time Frame: Month 0, 3 and 6 ]
  • Change From Baseline in Growth Velocity (GV) SDS at Month 6 [ Time Frame: Baseline and month 6 ]

    Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.

    Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures.

  • Difference Between Bone Age and Chronological Age [ Time Frame: Month 0 and 6 ]
    Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.
  • Uterine Length [ Time Frame: Month 0, 3 and 6 ]
  • Triptorelin Plasma Levels [ Time Frame: Month 1, 2, 3, 4, 5 and 6 ]
  • Follicle Stimulating Hormone (FSH) Response to GnRH Test [ Time Frame: Month 3 and 6 ]
  • LH response to GnRH test [ Time Frame: Month 6 ]
  • FSH and LH levels [ Time Frame: Month 1, 2, 3, 4, 5 and 6 ]
  • Estradiol levels in girls (the pre-pubertal range: ≤ 20 pg/ml) and testosterone levels in boys (the pre-pubertal range: ≤ 0.3 ng/ml) [ Time Frame: Month 1, 2, 3, 4, 5 and 6 ]
  • Inhibin B levels in girls (the pre-pubertal range ≤ 6 pg/ml) [ Time Frame: Month 3 and 6 ]
  • Pubertal stage (Tanner method) [ Time Frame: Month 3 and 6 ]
  • Height, weight and growth velocity [ Time Frame: Month 3 and 6 ]
  • Bone age variation (Greulich and Pyle method) [ Time Frame: Month 6 ]
  • The proportion of girls who achieve regression within pre-pubertal ranges of the uterine length [ Time Frame: Month 3 and 6 ]
  • Triptorelin Plasma Levels [ Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6 ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty
The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Precocious Puberty
Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
One intra muscular injection at day 1 and month 3.
Experimental: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Intervention: Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria in the screening phase:

  • Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys.
  • Weight ≥ 20 kg.

Inclusion Criteria in the treatment phase:

  • Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys.
  • Age at evaluation less than 9 years for girls and 10 years for boys.
  • A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).
  • Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) > 1 year.
  • Testosterone level ≥ 0.5 ng/ml in boys.

Exclusion Criteria:

  • Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.
  • Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.
  • Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).
  • The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00564850
2-54-52014-143
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Joelle Blumberg, MD Ipsen
Ipsen
February 2012

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