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

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.

Study Overview

• Status: Completed
• Conditions: Precocious Puberty
• Intervention / Treatment: Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49033
    • Hôpital Hotel-Dieu (CHU)
  • Besancon, France, 25030
    • Hopital Saint-Jacques
  • Bordeaux, France, 33000
    • Medical Centre
  • Dijon, France, 21034
    • Hôpital du Bocage
  • Le Havre, France, 76083
    • Hôpital Flaubert
  • Lille, France, 59037
    • Hôpital Jeanne de Flandre
  • Lyon, France, 69322
    • Hopital Debrousse
  • Marseille, France, 13385
    • Hôpital de la Timone Enfants
  • Nice, France, 06202
    • Hôpital Archet 2
  • Paris, France, 75019
    • Hôpital Robert Debré
  • Paris, France, 75015
    • Hôpital Necker - Enfants Malades
  • Paris, France, 75012
    • Hôpital Trousseau
  • Paris, France, 75014
    • Hôpital St-Vincent de Paul
  • Reims, France, 51092
    • American Memorial Hospital
  • Rouen, France, 76031
    • Hopital Charles Nicolle
  • Strasbourg, France, 67100
    • Hôpital Hautepierre
  • Tarbes, France, 65013
    • Hôpital de la Gespe
  • Toulouse, France, 31026
    • Hôpital des Enfants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triptorelin pamoate 11.25mg (Decapeptyl® SR)	Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR); One intra muscular injection at day 1 and month 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L	3 months after the first injection of triptorelin pamoate 11.25 mg

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L		Month 6
Follicle Stimulating Hormone (FSH) Level Following GnRH Test		Screening, month 3 and 6
Basal FSH Level		Month 0, 1, 2, 3, 4, 5, and 6
Basal LH Level		Month 0, 1, 2, 3, 4, 5 and 6
Number of Girls With Oestradiol Levels ≤ 20 pg/ml		Month 0, 1, 2, 3, 4, 5 and 6
Testosterone Level		Month 0, 3 and 6
Number of Girls With Inhibin B Levels < 6 pg/ml		Month 0, 3 and 6
Change From Screening in Pubertal Stage (Tanner Method) at 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'.	Between screening and month 6
Height Standard Deviation Score (SDS)	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.	Month 0, 3 and 6
Body Mass Index (BMI) SDS		Month 0, 3 and 6
Change From Baseline in Growth Velocity (GV) SDS at 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.	Baseline and month 6
Difference Between Bone Age and Chronological Age	Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.	Month 0 and 6
Uterine Length		Month 0, 3 and 6
Triptorelin Plasma Levels		Month 1, 2, 3, 4, 5 and 6

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: November 27, 2007
• First Submitted That Met QC Criteria: November 27, 2007
• First Posted (Estimate): November 28, 2007

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: 2-54-52014-143; 2005-005644-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).