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

Primary Purpose

Precocious Puberty

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precocious Puberty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Hotel-Dieu (CHU)
  • Hôpital Saint-Jacques
  • Medical Centre
  • Hôpital du Bocage
  • Hôpital Flaubert
  • Hôpital Jeanne de Flandre
  • Hôpital Debrousse
  • Hôpital de la Timone Enfants
  • Hôpital Archet 2
  • Hôpital Trousseau
  • Hôpital St-Vincent de Paul
  • Hôpital Necker - Enfants Malades
  • Hôpital Robert Debré
  • American Memorial Hospital
  • Hôpital Charles Nicolle
  • Hôpital Hautepierre
  • Hôpital de la Gespe
  • Hôpital des Enfants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triptorelin pamoate 11.25mg (Decapeptyl® SR)

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L

Secondary Outcome Measures

Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
Follicle Stimulating Hormone (FSH) Level Following GnRH Test
Basal FSH Level
Basal LH Level
Number of Girls With Oestradiol Levels ≤ 20 pg/ml
Testosterone Level
Number of Girls With Inhibin B Levels < 6 pg/ml
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'.
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.
Body Mass Index (BMI) SDS
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.
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.
Uterine Length
Triptorelin Plasma Levels

Full Information

First Posted
November 27, 2007
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00564850
Brief Title
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Acronym
DECAPUB
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precocious Puberty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Intervention Description
One intra muscular injection at day 1 and month 3.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
Time Frame
Month 6
Title
Follicle Stimulating Hormone (FSH) Level Following GnRH Test
Time Frame
Screening, month 3 and 6
Title
Basal FSH Level
Time Frame
Month 0, 1, 2, 3, 4, 5, and 6
Title
Basal LH Level
Time Frame
Month 0, 1, 2, 3, 4, 5 and 6
Title
Number of Girls With Oestradiol Levels ≤ 20 pg/ml
Time Frame
Month 0, 1, 2, 3, 4, 5 and 6
Title
Testosterone Level
Time Frame
Month 0, 3 and 6
Title
Number of Girls With Inhibin B Levels < 6 pg/ml
Time Frame
Month 0, 3 and 6
Title
Change From Screening in Pubertal Stage (Tanner Method) at Month 6
Description
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'.
Time Frame
Between screening and month 6
Title
Height Standard Deviation Score (SDS)
Description
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.
Time Frame
Month 0, 3 and 6
Title
Body Mass Index (BMI) SDS
Time Frame
Month 0, 3 and 6
Title
Change From Baseline in Growth Velocity (GV) SDS at Month 6
Description
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.
Time Frame
Baseline and month 6
Title
Difference Between Bone Age and Chronological Age
Description
Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.
Time Frame
Month 0 and 6
Title
Uterine Length
Time Frame
Month 0, 3 and 6
Title
Triptorelin Plasma Levels
Time Frame
Month 1, 2, 3, 4, 5 and 6

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Hotel-Dieu (CHU)
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital Saint-Jacques
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Medical Centre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Hôpital Flaubert
City
Le Havre
ZIP/Postal Code
76083
Country
France
Facility Name
Hôpital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Debrousse
City
Lyon
ZIP/Postal Code
69322
Country
France
Facility Name
Hôpital de la Timone Enfants
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital St-Vincent de Paul
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
American Memorial Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67100
Country
France
Facility Name
Hôpital de la Gespe
City
Tarbes
ZIP/Postal Code
65013
Country
France
Facility Name
Hôpital des Enfants
City
Toulouse
ZIP/Postal Code
31026
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

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

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