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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00564850
First received: November 27, 2007
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Precocious Puberty
 Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
 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: 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

Resource links provided by NLM:

MedlinePlus related topics: Puberty
U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Follicle Stimulating Hormone (FSH) Level Following GnRH Test [ Time Frame: Screening, month 3 and 6 ] [ Designated as safety issue: No ]
  • Basal FSH Level [ Time Frame: Month 0, 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  • Basal LH Level [ Time Frame: Month 0, 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  • Number of Girls With Oestradiol Levels ≤ 20 pg/ml [ Time Frame: Month 0, 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  • Testosterone Level [ Time Frame: Month 0, 3 and 6 ] [ Designated as safety issue: No ]
  • Number of Girls With Inhibin B Levels < 6 pg/ml [ Time Frame: Month 0, 3 and 6 ] [ Designated as safety issue: No ]
  • Change From Screening in Pubertal Stage (Tanner Method) at Month 6 [ Time Frame: Between screening and month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Growth Velocity (GV) SDS at Month 6 [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Triptorelin Plasma Levels [ Time Frame: Month 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptorelin pamoate 11.25mg (Decapeptyl® SR) Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
One intra muscular injection at day 1 and month 3.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564850

Locations
France
Hôpital Hotel-Dieu (CHU)
Angers, France, 49033
Hôpital Saint-Jacques
Besancon, France, 25030
Medical Centre
Bordeaux, France, 33000
Hôpital du Bocage
Dijon, France, 21034
Hôpital Flaubert
Le Havre, France, 76083
Hôpital Jeanne de Flandre
Lille, France, 59037
Hôpital Debrousse
Lyon, France, 69322
Hôpital de la Timone Enfants
Marseille, France, 13385
Hôpital Archet 2
Nice, France, 06202
Hôpital St-Vincent de Paul
Paris, France, 75014
Hôpital Necker - Enfants Malades
Paris, France, 75015
Hôpital Trousseau
Paris, France, 75012
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: Joelle Blumberg, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00564850     History of Changes
Other Study ID Numbers: 2-54-52014-143
Study First Received: November 27, 2007
Results First Received: November 1, 2011
Last Updated: February 9, 2012
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
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 May 19, 2013