Skip to main content
OpenTrials
Completed

NCT Number: NCT00564850

Efficacy and Safety Study of Pamoate of Triptorelin 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Precocious Puberty Endocrine System Diseases Gonadal Disorders Puberty, Precocious

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Hotel-Dieu (CHU), Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triptorelin pamoate 11.25mg (Decapeptyl® SR)

Drug

One intra muscular injection at day 1 and month 3.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L

    Time frame: Month 6

  2. Follicle Stimulating Hormone (FSH) Level Following GnRH Test

    Time frame: Screening, month 3 and 6

  3. Basal FSH Level

    Time frame: Month 0, 1, 2, 3, 4, 5, and 6

  4. Basal LH Level

    Time frame: Month 0, 1, 2, 3, 4, 5 and 6

  5. Number of Girls With Oestradiol Levels ≤ 20 pg/ml

    Time frame: Month 0, 1, 2, 3, 4, 5 and 6

  6. Testosterone Level

    Time frame: Month 0, 3 and 6

  7. Number of Girls With Inhibin B Levels < 6 pg/ml

    Time frame: Month 0, 3 and 6

  8. 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'.

  9. 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.

  10. Body Mass Index (BMI) SDS

    Time frame: Month 0, 3 and 6

  11. 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.

  12. 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.

  13. Uterine Length

    Time frame: Month 0, 3 and 6

  14. Triptorelin Plasma Levels

    Time frame: Month 1, 2, 3, 4, 5 and 6

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: DECAPUB

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 28, 2007
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.