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
2 other identifiers
interventional
37
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2007
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 27, 2007
CompletedFirst Posted
Study publicly available on registry
November 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
December 1, 2011
CompletedOctober 12, 2022
September 1, 2022
3 years
November 27, 2007
November 1, 2011
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
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
- +9 more secondary outcomes
Study Arms (1)
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
EXPERIMENTALInterventions
One intra muscular injection at day 1 and month 3.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (18)
Hôpital Hotel-Dieu (CHU)
Angers, 49033, France
Hôpital Saint-Jacques
Besançon, 25030, France
Medical Centre
Bordeaux, 33000, France
Hôpital du Bocage
Dijon, 21034, France
Hôpital Flaubert
Le Havre, 76083, France
Hôpital Jeanne de Flandre
Lille, 59037, France
Hôpital Debrousse
Lyon, 69322, France
Hôpital de la Timone Enfants
Marseille, 13385, France
Hôpital Archet 2
Nice, 06202, France
Hôpital Trousseau
Paris, 75012, France
Hôpital St-Vincent de Paul
Paris, 75014, France
Hôpital Necker - Enfants Malades
Paris, 75015, France
Hôpital Robert Debré
Paris, 75019, France
American Memorial Hospital
Reims, 51092, France
Hôpital Charles Nicolle
Rouen, 76031, France
Hôpital Hautepierre
Strasbourg, 67100, France
Hôpital de la Gespe
Tarbes, 65013, France
Hôpital des Enfants
Toulouse, 31026, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Endocrinology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2007
First Posted
November 28, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 12, 2022
Results First Posted
December 1, 2011
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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.