Clinical Trial: Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: 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 ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]


Information By: Ipsen

Dates:
Date Received: November 27, 2007
Date Started: October 2007
Date Completion:
Last Updated: February 9, 2012
Last Verified: February 2012